Pharma und Medizintechnik: Automation, CSV, MES, Serialisierung, Qualitätssicherung
Aktualisiert am 11.11.2024
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Manufacturing Execution Systems MES
Computer Software Validation (CSV) in Regulated Industries (Pharma/ Medical Devices)
Qualitätssicherung
Serialization (Track & Trace)
Commissioning and Qualification of Equipment
Methodenvalidierung
Automated Visual Inspection AVI
In-Depth Root Cause Analysis
IT Project Management
Auditing (certified Biomedical Auditor)
Quality Assurance
GMP
Engineering Change Projects
In-vitro Diagnostics IVD
Combination Products
Biotechnologie
Data Integrity
Czech
basic
English
excellent
French
respectable
German
native fluency
Italian
basic
Russian
excellent

Einsatzorte

Einsatzorte

Zürich, Basel, Hannover, Frankfurt, Berlin. (+500km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

5 Jahre 6 Monate
2017-07 - 2022-12

QA and Project Management

QA/ MES QA Lead and Project Manager
QA/ MES QA Lead and Project Manager

MES: Establishment of an MES application for PIC (Powder in Capsules, tabletting & steriles.

Root cause analysis:

  • Deviation, OOS, OOE and complaint handling for products of key customers related to release testing, solution prepa ration, sterile and aspetic filling of vials and ampoules, vi sual inspection, packaging and stability testing.

 

CAPA, change and project management:

  • Supported CAPA implementation, handled changes and performed FMEAs (failure mode effects analysis) for all vial and ampoule lines, implementation of new glass manage ment, optimization of filling lines related to glass breakage prevention, dispersion of glass particles in case of glass breakage events, reduction of glass to glass and metal to glass contact, optimization of setup process for filling and crimping stations, FMEAs for blind spots of semi and fully automated visual inspection (AVI), optimization of AVI and full revalidation incl. Knapp study, optimization of test instructions for HPLC analysis of assay and known and unknown impurities of specific drug products, optimization of production planning and order fulfillment, improvement of plant logistics and WIP (work in process) storage facilities to ensure cold chain for refrigerated products.

 

Customer & Healthcare Authority Audits:

  • Preparation of customer and healthcare authority audits.
  • Support during ANVISA, FDA and Russian Heathcare authority audits.

 

Investigation lead:

  • Investigation lead during significant investigation initiatives involving glass and stopper vendors.

 

Key account management:

  • Single point of contact for Merck Sharp and Dohme for all deviation, OOS, OOE, CAPA, complaint, validation, product transfer, regulatory and supply related topics.

 

Training/ SOPs:

  • Improvement of test instructions, creation of new glass breakage procedure, improvement of laboratory organization of IPC and release sample testing and associated SOPs, new SOP for handling of glass breakage events at the vial and ampoule filling lines, training of shopfloor staff how to perform discarding of glass contaminated objects after glass breakage incidents whether witnessed or unwitnessed, training how to apply root cause investigation tools
Siegfried AG, Merck CPD, BAYER AG
9 Monate
2017-04 - 2017-12

Factory Automation

Project Manager Factory Automation
Project Manager Factory Automation

secundary project

Melsungen for Greenfield project in Rumania

  • Creation of Process description for incoming and release testing, plant logistics, weighing & dispensing, solution preparation, filling (blow fill seal technology), visual inspection sterilization and packaging for LVP (large volume parenterals), In- process controlls (IPC).

IT & automation concept:

  • Development of automation concept and IT Infrastructure concept, creation of URS, FRA (functional risk assessments) & tender documentation, Workshop preparation and moderation, scheduling & budgeting of activities.   
bCB.Braun
10 Monate
2016-06 - 2017-03

Global MES (Manufacturing Execution System) implementation of Large Volume Parenterals (LVP) & Medical Device Disposables

Interim Project Management
Interim Project Management
  • Planning and managing of analysis, design, build and deployment phases for Pharma template, Medical Device template and ERP adapter (for SAP ECC).
  • Technical guidance on Core documentation (URSs, Validation Master Plan, GxP & ERES Assessments, Functional Risk Assessments, traceability matrix), organisation and moderation of workshops and Steering Committee meetings, development of validation concept, development and establishment of infrastructure concept for global QA, site QA and Productive systems, development and implementtion of harmonization concept for eBR (electronic btach records), MBR design training, establishment of site deployment plans for the production sites in Italy, Poland and Hana (Carribean).
Fresenius Group Bad Homburg
6 Monate
2016-07 - 2016-12

SME for global Track & Trace Implementation for CoE

secundary project

  • Setup of global Track & Trace project by definiton of core strategy, creation of Track & Trace system description, definition of IT- Infrastructure concept for all B.Braun sites, VMP (validation masterplan), Core Track & Trace URS, Functional Risk Assessment (FRA), URS for local/ site Track & Trace systems, FRA, URS for global SAP Track & Trace system (SAP ATTP), FRA, development of offline print centers for fixed layouts and variable data. 
B.Braun AG, Melsungen
6 Monate
2015-11 - 2016-04

Preparation of Core Documenation for leveraged commissioning

Validation Expert
Validation Expert

Preparation of Core Documenation for leveraged commissioning for complex Track & Trace labelling and packaging hard- and software solutions for leading Pharmaceutical companies such as Novartis, Sandoz, Bayer, BMS, Sanofi, Boehringer Ingelheim.

 

Related Equipment:

  • Flight Conveyer, Checkweigher and integrated solutions for item serialization,
  • aggregation and dis-aggregation (items to bundle to case to pallet), incl. interfaces to MLS Multiline server, SAP Aii & ATTP, MES (Werum PAS- X).    
  • Prepared, updated Configuration Matrices, Functional Specifications, Hardware Design Specifications, Validation Plans, test scenarios for System tests, FAT (factory acceptance test) testpalans, SAT (Site acceptance test) testplans and product updates of core documents for customers such as Parameter setting lists and Traceability matrices.  

 

Root Cause Analysis:

  • Supported software department in moderating root cause analysis to identify cause for data base inconsistencies, for instance time stamp errors, incorrect batch data, verified correct export of batch data from Single Unit to Multi Line Server and export to SAP Aii.

 

Impact Assessments:

  • Conducted Impact Assessments for changes, created installation procedures for software updates and associated test plans.    
Traxeed (previously Seidenader Maschinenbau Track & Trace, Munich)
11 Monate
2015-02 - 2015-12

UDI implementation, CAPA related activities

Labelling Expert
Labelling Expert

UDI implementation:

  • Identified and resolved gaps in bespoke packaging and labelling software, implemented neccessary changes due to UDI (Unique Device Identifier) requirements, created Validation Plan, updated URS, conducted FRA, created traceability matrix and required test plans for label creation software part and for label printing at packaging lines, managed IQ/ OQ and PQ with a small team, created cutover plan, trained the plant team and successfully implemented the new GAMP5 category SW version on the shopfloor.

 

CAPA related activities:

  • In parallel implemented nomenclature of product desciptions and arranged CAPA related proper translation of about 10000 items into the 25 languages of the target markets.
Zimmer Biomet GmbH, Winterthur
1 Jahr 9 Monate
2013-04 - 2014-12

commissioning and qualification of the New Solids Launch Facility

Senior QA Expert and Training Manager
Senior QA Expert and Training Manager
  • Ensured compliance to the Novartis Quality Manual and Good Manufacturing Practice of all activities related to commissioning and qualification of the New Solids Launch Facility for Novartis PharmOps covering utilities, process equipment (OSD oral solid drug manufacturing/ inhalation drug manufacturing) packaging, Plant Automation, IT Systems, Manufacturing Execution System and laboratory equipment.
  • Reviewed engineering documentation such as URSs, Functional Risk Assessments, Qualification Plans, Design documents (drawings, R&ID - process and instrumentation diagrams), Qualification Reports, IQ, OQ & PQ testplans and reports, Validtion plans and protocols to assure accordance with GMP regulations and the Novartis Quality Manual.

 

Training concept & Delivery:

  • Developed training plan and matrix according training needs of different job roles within the project, created standard operating procedure and implemented training at NSLF, mainained scheduling by LMS electronic training system and monitored training performance of all team members. 
  • Delivered classroom based GMP, Deviation handling, CAPA handling, Validation and Qualification and Testplan training.

 

Audit Program:

  • Developed and established Self- Inspection program and conducted Self Inspections as the lead auditor to drive continuous im improvements.

 

Deviation & CAPA handling:

  • Established Deviation Handling and CAPA system, conducted Root Cause Analysis and assessed impact of deviations from predetermined acceptance criteria.

 

Vendor evaluation:

  • Managed vendor selection, evaluation and CARs (ANA Audit Need Assessments, Corrective Action Requests)
OVARTIS NSLF (New Solids Launch Facility)
10 Monate
2012-09 - 2013-06

Re-engineering of compounding section

  • Successfully re- organized cleaning, sterilization and compounding section of Novartis Steriles by implementing work stations, 5S; established and executed classroom based and on the job training (OJT) and qualification of personnel in sterilization processes, compounding and filtration, established new layout of cleaning section, developed URSs for new equipment, accomplished various projects to qualify new cleaning and sterilization equipment and optimized loading schemes and recipes for autoclaves.
NOVARTIS CH Stein, Steriles
5 Monate
2012-04 - 2012-08

Implementation of ISO 13485/ development and CE marking of autoinjector device

Quality, regulatory and development related activities:

  • Established and implemented Quality Management System for Medical Devices according ISO13485 and cGMP requirements of QSR 820 CFR21 for the US market into already existing structure of the Pharmaceutical organization.
  • Created Quality Manual, top level SOPs such as Management Reviews, Design and Development, Internal Quality Audits, CAPA, Post Market Surveillance Activities and Supplier Management- established a supplier selection, evaluation, qualification and effective performance repor- ting system with KPIs, established an effective CAPA process  based on a risk evaluation matrix with adequate root cause analysis tools, CAPA plans and evaluation of effectiveness.

 

Regulatory and product development activities:

  • Support of development activities of the SUREPAL PEN drug delivery device with new drug dosis and associated documentation for 510K and CE- Marking.
SANDOZ Bio- Pharmaceuticals, Kundl, Austria
4 Monate
2011-12 - 2012-03

510 (k) PMN filing of a complex CAD/ CAM platform for dental prosthetics

  • Managed large cross functional team with various suppliers for 510 (k) PMN (premarket notification) filing of a complex CAD/ CAM platform for dental prosthetics such as crowns, copings, implants, supra structures and bridges.
  • Conducted gap analysis regarding necessary documentation for successful filing of Medical Device software with FDA “Moderate Level of Concern”, created templates and necessary documents for architectural design, Software Requirement Specifications (SRS), Software Design Specifications (SDS), Conducted risk analysis, planned and conducted verification & validation activities, performed Traceability Analysis and ensured appropriate Configuration and Life Cycle Management.

 

Update of Quality Management System (QMS):

  • Gap analysis of existing QMS, adjustment of various subsystems of organization´s Quality Management System for the new software product not covered by the existing QMS of the company
ZIMMER Dental, Carlsbad, CA
7 Monate
2011-05 - 2011-11

Adjustment of an Invitro Diagnostic (IVD) platform & successful registration of a drug/ device combinantion pruduct

  • Improvement of IVD platform for an IHC immunohisto- chemical assay, review and adoption of existing documentation and successful validation.
  • Clinical trail support, regulatory support for market release of combination product “drug/ in- vitro diagnostic” for a new indication (lung cancer NSCLC) of an existing cancer therapeutics.
MERCK SERONO, Darmstadt
1 Jahr 7 Monate
2009-10 - 2011-04

Gap assessments, development of improvement roadmaps and implementation.

Senior Consultant and Associate
Senior Consultant and Associate
  • Juran Institute, Inc. provides training, certification, and consulting services to organizations, focused on quality management including services such as lean, lean six sigma, benchmarking, problem solving, cost reduction, innovation, quality planning, quality improvement, quality control, Baldrige assessments, and continuous improvement, catering to organizations in healthcare, service providers, manufacturing, finance, automotive, education, government, and oil and gas sector.
  • Gap analysis between approach and deployment of company´s business operating system (BOS) e.g for Johnson controls within 160 plants to gain baseline, to identify weaknesses, to develop and implement QIR ( Quality Improvement Roadmap).
  • Conducted various audits as a lead auditor in electronic, interior, metal plants to analyze and score the following subsystems:
    • Management
    • Customer Firewalls
    • Product Safety Certification
    • Quality Systems
    • Supplier Quality
    • Corrective Action
    • Problem Solving, 5S/ 6S, Error Proofing
    • Standard Work
    • Kaizen
    • Tooling and Equipment
    • and Engineering Resources to identify areas for improvements, developed and success fully implemented improvement roadmaps.
Juran Institute, Southbury, Connecticut.
7 Jahre 1 Monat
2002-09 - 2009-09

Reorganization of Dentronic and preparation for implement of QMS according ISO 13483 standards

Managing Diretcor/ Partner
Managing Diretcor/ Partner
  • Dentronic was trading dental accessories and units and besides that has started to develop and manufacture devices for dental instruments. Conducted gap analysis, set a framework for the QMS, reviewed existing documentation and closed identified gaps within Device Master Files (DMRs) Device History Records (DHFs), created SOP´s, defined Quality policies, Quality management principles and objectives, Quality guidelines for each function and Q- Plans.
  • Defined processes for non- conformance and CAPA handling, defined and aligned sales, marketing, procurement, production and supporting processes (order process, personnel management, complaint handling, communications, labelling, storage & dispatch), defined and set in place performance measurement system, process measurement & analysis of quality relevant processes, trained and intro-duced QM system to employees, defined supplier selection criteria, evaluation of suppliers and type and extent of control for incoming material to meet specified requirements.
  • ISO 13485 QM System was successfully approved by LRQA, Cologne

 

New product development of dental device- control system for dental drills and scalers (rotation speed and torqueDesigned project and deliverables:

  • Work Breakdown, Gantt Chart, Activity network diagram, critical path, defined and maintained project evalution, resource management and budget.
  • Closely worked with R & D departments, head of regulatory affairs, procurement, marketing and international 

    subsidiaries of business partner of a Swiss Dental company and sucessfully developed a device for precisely controlled speed range 20 – 40000 rpm and with 1:5 contra angle up to 200000 rpm, change of rotation, torque control for dental applications such as root canal treatments, cavity preparations, gross caries removal & bone surgery with 4 preselectable speed and power levels and automatic reverse function.

  • In 2006 the ADA (American Dental Association) tested performance of dental instruments of the 8 leading manufacturers in the world and theSwiis dentral drill controlled by the Dentronic Device was the only instrument reaching pricesely the target rotation speed of 40k rpm and 200k rpm with 1:5 contra angle.

The product was launched as a package including BienAir MX mirco-motor with Dentronic “Optima T+R” control device in the US market and Europe.  

 

Developing, implementing and maintaining a Supply Chain Management system:

  • According to requirements of Quality Management System and the desire of achieving higher performance by reducing variation in the processes, better utilizing resources and more focussing on value stream reduced number of vendors and to established formal process for collecting, analyzing and reporting supplier performance. Identified and defined external customer´s requirements and needs by customer surveys, focus groups, questionnaires e.g., identified internal customer interfaces, their needs, performed gap- analysis, set improvement objectives & measurements, implemented system for tracking & reporting performance and for continuous improvement, defined and negotiated QLA.
  • Communicated product & process requirements, order & delivery requirements and safety & environmental requirements to suppliers, established supplier scorecard with metrics for PPM, accuracy, timeliness, completeness, responsiveness, return of rework, technical support given, supplier performance Cpk and supplier process Ppk to periodically compute numeric score along with total score and category labels.
  • Developed certification process to foster relationship with labelled suppliers to reduce inventory with various interim steps ( from ship to stock – JIT) to end up with modular assembly

Continuous Improvement with SIX SIGMA tool box

  • To reduce lead time to completion, to improve quality significantly and to optimize the overall performance implemented Six Sigma DMAIC- cycles in all departments of the organization ( sales, marketing, procurement, production, delivery and service). Analyzed processes and sub-processes at all levels and defined areas for improvement
  • At a very early stage reduced cycle by eliminating non value added work by simplifying and streamlining processes, reduction of unnecessary complexity, reduced motion, conveyance, overproduction, overprocessing, waiting, inventory, correction and rework.
  • Created an "As- Is" and developed a "Should- be" process map, trained and coached staff with process improvement tools for defining, measuring data, analyzing data (e.g. root cause analysis tools, cause & effects diagram, process mapping), tools for improving and control (failure mode effects analysis, Statistic Process Control), identified projects for improvements, built cross- functional teams, defined problems, developed project charter, gathe- red data, validated measurement & measurement system, determined baseline levels, baselined capability and Sigma levels, determined and quantified performance objectives, analyzed data, root causes or key factors for process variation, identified or selected solutions, defined implementation by action plans, communicated solutions to all stakeholders, implemented solutions and monitored improvements versus objectives, replicated and standardized improvements.
on request

Aus- und Weiterbildung

Aus- und Weiterbildung

1983 ? 1987

  • Johannes Gutenberg University Mainz
  • Master; Major in Communication Science, Minor in Russian and political science

Training

  • Lean Concepts, Kaizen, Kanban, Taguchi, Hoshin Planning, Quality Models &Theories: BNQP, EFQM, TQM, CQI, Leadership, Strategic Plan Development &Deployment, Quality Management Philosophies, Problem Solving Tools, Process Management Tools, Process Improvement tools, Supply Chain Management ( Supplier Selection, Ranking, Scoring, Certification), Needs Assessment Techniques and Tools, Curriculum Development &Delivery, QSIT FDA inspection techniques.  

Regulatory Agency Governance:

  • Global Regulatory Framework
  • Regulations &Guidances
  • Mutual Recognition Agreements
  • Regulatory and Health Authority Inspections
  • Enforcement Actions
  • Regulatory Agency Reporting
  • Post- Marketing Changes
  • Regulatory Reporting Requirements

Site master file (SMF) and drug master File (DMF)

Quality Systems:

  • Quality elements, QMS requirements
  • Quality Unit site Management
  • Risk Management
  • Training &Personnel Qualification ( Needs analysis/ Staff development requirements)
  • Change Control ( pre- change analysis/ Post- change analysis)
  • Investigations &CAPA ( trigger events, response actions, CAPA feedback & trending)
  • Audits &Self inspections
  • Documents &Records Management (GMP document system, GMP com-pliance records, record retention)
  • Product Quality complaints vs. adverse event reports (quality complaints, ad- verse Events &pharmacovigilance, problem response)
  • Product trend requirements
  • Supplier &contractor Quality Management ( supplier Q systems, supplier control, supplier evaluation)

Laboratory systems:

Compendia ( marketing requirements, Compendial methods review, compendial requirements review/ biological, microbiological, chemical and physical test methods)

  • Laboratory investigations of aberrant results (test data/ aberrant results)
  • Instrument control &record keeping (instrument control &calibration)
  • Specifications ( types of specifications, test data, specifications revision
  • Laboratory record keeping and data requirements ( COAs certificate of analysis), stability programs
  • Reverse samples and retrains

Infrastructure:

  • Facilities: -  Buildings
  • Manufacture &Storage environment
  • Facilities change control
  • Utilities: -  water supply systems
  • Compressed air and gas systems
  • Utility design for production
  • Utilities change control
  • Equipment: -   equipment planning/ layout/ cleaning & maintenance, validation &verification, change control

Maintenance and Metrology Systems:

  • Maintenance procedures &change control

Cleaning, sanitization and sterilization systems

Automated or computed systems:

  • Validation procedures
  • Open and closed computerized systems
  • Configuration control
  • Security requirements

Business continuity and disaster recovery planning:

  • Supply chain impact
  • Contingency plan

Materials &Supply Chain Management:

  • Incoming materials
  • Sampling process
  • Material storage, identification &rotation
  • Shipping &distribution
  • Traceability &sourcing
  • Salvaged, returned goods &destruction

Sterile and Nonsterile Manufacturing Systems

  • Filling, Packaging &labeling

Product Development &Technology Transfer:

  • Critical by design concepts (critical Quality attributes and critical process Parameters/ design space, PAT Process Analytical tools)
  • phase appropriate GMP requirements
  • raw materials and infrastructure for product development
  • new product development studies & reports scale- up and transfer activities 

 

Certification

  • ASQcertified Manager of Quality and Organizational Excellence
  • ASQcertified Six Sigma Black Belt
  • ASQcertified Biomedical Auditor
  • ASQcertified Pharmaceutical GMP Professional
  • ASQcertified Software Quality Engineer
  • NOVARTIS PharmOpscertified Trainer

Kompetenzen

Kompetenzen

Top-Skills

Manufacturing Execution Systems MES Computer Software Validation (CSV) in Regulated Industries (Pharma/ Medical Devices) Qualitätssicherung Serialization (Track & Trace) Commissioning and Qualification of Equipment Methodenvalidierung Automated Visual Inspection AVI In-Depth Root Cause Analysis IT Project Management Auditing (certified Biomedical Auditor) Quality Assurance GMP Engineering Change Projects In-vitro Diagnostics IVD Combination Products Biotechnologie Data Integrity

Produkte / Standards / Erfahrungen / Methoden

Profile

I am a Principal Consultant, ASQ certified Manager of Quality and Organizational Excellence, certified Biomedical Auditor, certified Pharmaceutical GMP Professional, certified Software Quality Engineer and Six Sigma Black Belt with more than 15 years experience in regulated industries, provided with extensive Project Management, Quality Assurance/ Compliance, Audit, Regulatory Affairs, Engineering and Vendor Management experience from medium size to large scale projects in Pharma and Medical Device industries with a strong shopfloor affinity to production processes (Pharma: Oral Solid Dosage/sterile / inhallation drug manufac-turing/ packaging; MedTech: Drug Delivery, IVD, implant/ disposables/ dental device manufacturing) as well as business processes.

Achievements in previous roles and projects:

  • Successfully managed all stakeholders as a global Pro-ject Manager at Fresenius Group SE within a global MES implementation program as part of a global SAP rollout, trained internal customers in Requirements Engineering, supported URS, ARIS process modelling, ERP adaptor and level 2 interfaces for global Pharma template (preparation, glass &blow fill for intravenous infusions) and Medical Device template for manufac-turing of disposables, defined both, infrastructure and validation concept, supported creation of VMP and crea-ted and implemented deployment plans for all 4 pilot sites.
  • Created successfully all engineering documents for B.Braun CoE for Pharmaceuticals, URS, FRA, VMP for global Track &Trace System, for Site Manager, SAP Track &Trace  and Print centres as a starting point for local site activities.  
  • Supported launch of a new, sophisticated labelling/ packaging software as a Validation Lead at Seidenader Track &Trace for item serialization and aggregation (item?case?pallet) for pharmaceutical products, created test case scenarios for FAT/ SAT to verify correct upload of batch/ material data from WERUM MES/ SAP to Muli Line Servers and line controllers and proper import of batch data to Multi Line Server/ PI Historian/ SAP Aii/ ATTP for Core Releases (Novartis/ Sandoz/ Bayer/ BI/BMS).
  • Successfully implemented UDI (Unique Device Identi-fiers) in a time critical project for 4500 implants as a Project Manager at Zimmer Biomet by adopting comprehensive software changes to label creation and printing software linked to SAP, personally revised complete documentation (URS/ FRA/ Configuration Matrix) and validated software with a small team for all lines envolved.
  • As a Senior Quality Expert at Novartis NSLF (New Solids Launch Facility/ large scale project):
    • successfully supported deployment of a GxP compliant   IT/ Automation concept, high level architecture as well as detailed design for an automated, paperless oral solid and inhalation drug (highly actives) manufacturing site with an associated laboratory integrating SAP/ PI Historian/ MES/ OPC/SCADA/LIMS.
  • Launched internal audit program and conducted self inspections as a Lead Auditor at Novartis NSLF to drive continous improvement and get prepared  for Health Authority inspections.
  • Effectively implemented and maintained training system and delivered GMP, CSV, Test plan training e.g. as Novartis NSLF Training Manager for project management team and 150 engineers.
  • Successfully ensured compliance to the Novartis Quality Manual and Good Manufacturing Practice of all activities related to commissioning and qualification of the New Solids Launch Facility for Novartis PharmOps covering utilities, all process equipment (OSD oral solid drug manufacturing/ inhalation drug manufacturing), Packa-ging, Plant Automation, Manufacturing Execution Sys-tem, and laboratory equipment. Conducted Supplier Assessments.
  • Successfully re- organized cleaning, sterilization and compounding section of Novartis Steriles as a Project/ Change Manager by implementing work stations, 5S, establishing and executing classroom based and on the job trainings and qualification of personnel in steriliza-tion processes, compounding and filtration, established new design of cleaning section, developed URSs for new cleaning equipment, accomplished various projects to qualify new cleaning and sterilization equipment and optimized loading schemes and recipes for autoclaves.
  • Successful CE marking for various class II, III Medical Devices (dental devices/ injection devices), FDA 510 (k) PMN and PMA for Medical Devices (CAD/CAM Dental Software, In- vitro Diagnostic platform, Dental Devices) as a Regulatory Affairs Consultant for Sandoz Bio Pharmaceuticals, Zimmer Dental, Merck Serono.
  • Participated in large scale improvement initiatives as a Senior Consultant of the Juran Institute Connecticut, analyzing, modeling and virtualizing production and business data to evaluate the approach and deployment of operational excellence, to identify areas for improve-ments and successfully developed and implemented Quality Improvement Roadmaps for various manufac-turing sitres in different industries.

 

I am well- provided with a sound understanding of Automation Concepts, IT infrastructure, all manufacturing and Lab processes, data requirements, analysis and utilization. 

Professional Background

2011 - today

  • Name on request
  • Owner and Principal Quality Assurance/ Compliance, Regulatory Affairs, Engineering  &Validation Consultant (manufacturing equipment/ software) 

2009 - 2011

  • Juran Associate, Connecticut, USA 
  • Senior Management Consultant, Lead Auditor
  • Plant Assessments, Development of Improvement

1988 ? 2003

  • Name on request
  • Managing Director, Incentive and Congress Management Agency

 

1983 ? 1987

  • Professional Employ-ment accompanying university studies
  • First experience in congress management at Wurzburg Congress Center, business development, sales and marketing

1979 ? 1983

  • German Army, Intelligence Service
  • Bundessprachenamt, Cologne
  • Army, Officer Special Task Force - Intelligence Service
  • 18 months intense courses in Russian and Czech level 4

Key competencies

Leadership Competency

  • Staffing, training, motivating, influencing, negotiating, KESAA, MBTI-Myers Briggs Type Indicator
  • DISC, Empowerment, Change Manage-ment, team building, team performance &evaluation.

Professional Competency

Compliance audits and performance analysis:

  • within High Level Quality Systems cGMP, GCP, GLP, GDP, GAMP5,

FDA regulation of Medical Devices:

  • QSR 21 CFR 820 Management Responsibility, Design Controls, Documentation &Change Control, Purchasing Controls, Identification and Traceability, Production &Process Controls
  • Process Validation, Cali-bration, CAPA, Packaging &Labeling Controls, Handling, Storage, Dis-tribution &Installation, Labelling, Medical Device Reporting, Recalls, Corrections &Removals
  • Device Tracking, Electronic Records and Sig-natures, In- Vitro- Diagnostic Products, Design Reviews, Risk Manage-ment, QSIT Quality System Inspection Techniques

Technical Knowledge:

  • Sterilization, Biocompatibility, Controlled Environment and Utility Systems, Software, Laboratory Testing, Environmental Monitoring: Aseptic Processing Facility design
  • Air Monitoring ( viable particulates, nonviable particulates, surface sampling, personnel monitoring, data analysis, LAL test, sterility testing, qualification &validation

 

International Standards:

  • EU Medical Directives AIMD, MDD &IVDD, International Auditing Guidelines, Regulatory Requirements, Complaint Handling
  • Capacity &Resources Management,  Process and product audits, development of Quality Improvement Roadmaps

Supply Chain Management:

  • Supplier Selection, rating, supplier performance audits &certification

Specific knowledge:

  • Dental technology management, sound knowledge of dental treatments endodontics, periodontology, implantology and restorations (Instru-ments, treatment centers, Imaging CBVT/ CLSM and CAD/ CAM and integrated solutions), In- Vitro Diagnostics (autostainer for tumor membranes, IHC, reagents, workflow parameters)
  • Oncology: biomarkers, cancer therapeutics for CLC, NSCLC, breast cancer, Combination
  • Products: drug/ IVD, regulatory requirements for Co-filing, injection devices and inhalers.
  • Plant automation systems, Manufacturing Execution systems
  • Track &Trace- Serialization &Aggregation

Methodic Competency

Environmental Analysis:

  • SWOT, Market Forces, Competitive Analysis, Benchmarking, Stakeholder Analysis, Technology Analysis, Internal Capability Analysis
  • Supplier Assessments, Customer Assessments, Legal &Regulatory Analysis

Problem Solving Tools:

  • Ishikawa, Pareto, Run-/ Control charts, Scatter Diagrams

Management Tools:

  • Affinity Diagram, AND, CPM, PERT, Gantt Chart, Interrelationship Diagraph
  • Matrix Diagram, Priorities Matrix, PDPC, Tree Diagram, RRM, LRM

Process Improvement Tools:

  • Rapid Root Cause Analysis, 5 Why´s, PDCA/ PDSA cycle, SIPOC, DFMEA/ PFMEA
  • Six Sigma DMAIC, SPC, Process Improvement Model, TOC ? Theory of Constraints

Innovation &Creativity Tools:

  • Brainstorming, Mind Mapping, Analogies, Normal Group Technique, Multi- Voting, Lateral Thinking 
  • Critical Thinking, DFSS/ DFMA, TRIZ, Story Board, Scamper

Lean Tools:

  • Cycle Time Reduction, VSM, Five ?S?, / 7 Muda ( Waste Reduction), Visual Management, Poka Yoke, Set Up/ Change over Time Reduction, TPM, Kaizen Event, Kanban, JIT, Takt Time
  • Line Balancing, Standardized Work, Single Piece Flow, Cellular Operations, CE/ SE Simultaneous Engineering, Outsourcing, Business Process Engineering

Change Management:

  • Force Field Analysis

Risk Management:

  • FMEA, FMECA, FTP, PHA, JHA, HACCP,  HAZOP

Statistics:

  • Statistic Process Control, Confidence Intervals,  Sampling, Measurement Variation Analysis, Gage R&R, Multi Vari Charts, Pugh Matrix, Conjoint analysis, DoE (Orthogonal Arrays, Fractional Fractorials, Variation Reduction &Centering of the Mean, e.g.)
  • Value Added Analysis, Statistical risks, ANOVA, ANOM, Bartlett´s, Non Parametric Tests, Hypothesis testing, FMEA- RPN, Anticipatory failure analysis, Manufacturing Controls, Correlation &Regression Analysis,, SMED, RETAD, Lot sizing.

Project Management:

  • NPV, IRR, ROI, ROA, risk analysis, feasibility assessment, WBS, AND, Critical Path Method, PERT, measurement &tracking, budget variance, EVA

Strategic Competency

  • Organizational structures, Organizational culture, Corporate-, Business- &Functional Strategies,
  • Strategic Plan Development &Deployment: Action Plans, Resource allocation and deployment, organizational performance measurement, BSC- Balanced Scorecard, Function in strategic deployment, Porter?s 5 Forces, PRESTEL, SRD (Success Resource Deployment) Generic Positioning, Outpacing Strategies, McKinsey 7-S Framework
  • Product Lifecycle Management, Target Costing/ Target Pricing, Contract Negotiation Techniques, Performance Contracting, Training Plans Aligned with Strategic Plans, Training Needs
  • Analysis, Curriculum Development &Delivery, Integrated Training Programs, Measurement &Effectiveness

Analytical Competency 

  • Business Environment Analysis: SWOT, Market Forces, Stakeholder Analysis, Technology, Internal Capability Analysis, Legal &Regulatory Analysis, Gap Analysis, Financial Analysis/financial resources, Balance Sheet, P&L Income Statement, Cashflow Analysis, non- routine analysis for special purposes, special tax issues national/ international, budget planning,Due Diligence, Product profitability, Make-or-Buy- analysis, Product/ Service cost structures, Activity based costing, Total Cost of Ownership, Return on Investment, ROA, COQ Cost of Quality, ROTI
  • Legislation: EU legislation, US legislation, Health Canada, TGA Australian Guidelines, Japan

Global Regulatory Frame work

Regulations &guidances:

MedicalDevices incl. In- Vitro Diagnostics

  • MDD:93/42/EWG, 90/385/EEC, 2007/47/EEC for AIMD, MDD, IVDD, FDA: QSR 21CFR 820

Pharmaceuticals:

  • Dir: 2001/82/EC, 2001/83/EC, 2004/27/EC
  • Reg. EC/1901/2006. EC1394/2007
  • FDA 21CFR 211/212, USDA 9CFR
  • US-Pharmacopoeia, EP, JP

Quality Assurance:

  • ISO9001, ISO13485, ISO14644, ISO17025
  • WHO- GMP, EU- GMP, FDA- cGMP, GLP, GCP, GAMP5

Regulatory inspections:

  • PAI, system- based, for-cause, license-renewal

 

Regulatory reporting:

  • Post Marketing Changes, Annual reporting
  • 21CFR 314, subpart H/ 21CFR 601, subpart E

                 

Mutual Recognition

Agreements:

  • ICH, PIC/s, IPEC

IT Competency Software

  • Software Quality Management, Systems &Software engineering processes, system architecture, Requirements Engineering (Caliber/ Silk, e.g.), Software Metrics and Analysis, Configuration Management, Risk Management, Reviews &Inspections, Software Validation
  • Software audits, Data Analysis, modelling and virtualization (JBoss, e.g.), integration of data sources SAP Aii, SAP R/3, PI Historian, MLM/MLS, MES, LIMS, OPC, SCADA.

International Intercultural´Competency

  • More than 20 years experience and deep knowledge of ethnics, mentalities and culture in dealing with business partners, officials, government organizations in ASIA, North America, Latin America, Middle East, Africa, Russia, CIS and Europe, strong problem solving abilities, even in critical situations.

 

Soft Skills

  • results driven, logical and methodical approach achieving tasks and objectives
  • excellent analytical, organizational and leadership skills
  • effective and open communication at all levels/ with all interfaces, confident and persuasive
  • excellent problem solving abilities
  • empathic: facilitator and enabler
  • highly motivated to overcome hurdles and constraints to make good things better

Strengths:

  • I have strong analytical, project management and communication skills as well as a comprehensive background of root cause analysis and process improvement tools, in depth knowledge of global Medical Device and Pharmaceutical Quality System requirements, regulatory strategies, Quality System Inspection techni-ques and production processes and equipment in both industries including GMP compliant equipment qualification and process validation standards. 
  • I am used to work within complex scenarios asking for strong analytical, excellent planning, problem solving, communication and execution abilities.       

Branchen

Branchen

  • Medical Device Industry: dental and surgical instruments, implants, Invitro- diagnostics, CAD/ CAM software for dental restorations, drug delivery devices
  • Pharmaceuticals Industry: Aspetic processing, oral solid and inhalation drug manufacturing, packaging and labelling, process analysis, process validation and equipment qualification, Lab processes and euipment, batch data analysis, Deviation &CAPA handling

Einsatzorte

Einsatzorte

Zürich, Basel, Hannover, Frankfurt, Berlin. (+500km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

5 Jahre 6 Monate
2017-07 - 2022-12

QA and Project Management

QA/ MES QA Lead and Project Manager
QA/ MES QA Lead and Project Manager

MES: Establishment of an MES application for PIC (Powder in Capsules, tabletting & steriles.

Root cause analysis:

  • Deviation, OOS, OOE and complaint handling for products of key customers related to release testing, solution prepa ration, sterile and aspetic filling of vials and ampoules, vi sual inspection, packaging and stability testing.

 

CAPA, change and project management:

  • Supported CAPA implementation, handled changes and performed FMEAs (failure mode effects analysis) for all vial and ampoule lines, implementation of new glass manage ment, optimization of filling lines related to glass breakage prevention, dispersion of glass particles in case of glass breakage events, reduction of glass to glass and metal to glass contact, optimization of setup process for filling and crimping stations, FMEAs for blind spots of semi and fully automated visual inspection (AVI), optimization of AVI and full revalidation incl. Knapp study, optimization of test instructions for HPLC analysis of assay and known and unknown impurities of specific drug products, optimization of production planning and order fulfillment, improvement of plant logistics and WIP (work in process) storage facilities to ensure cold chain for refrigerated products.

 

Customer & Healthcare Authority Audits:

  • Preparation of customer and healthcare authority audits.
  • Support during ANVISA, FDA and Russian Heathcare authority audits.

 

Investigation lead:

  • Investigation lead during significant investigation initiatives involving glass and stopper vendors.

 

Key account management:

  • Single point of contact for Merck Sharp and Dohme for all deviation, OOS, OOE, CAPA, complaint, validation, product transfer, regulatory and supply related topics.

 

Training/ SOPs:

  • Improvement of test instructions, creation of new glass breakage procedure, improvement of laboratory organization of IPC and release sample testing and associated SOPs, new SOP for handling of glass breakage events at the vial and ampoule filling lines, training of shopfloor staff how to perform discarding of glass contaminated objects after glass breakage incidents whether witnessed or unwitnessed, training how to apply root cause investigation tools
Siegfried AG, Merck CPD, BAYER AG
9 Monate
2017-04 - 2017-12

Factory Automation

Project Manager Factory Automation
Project Manager Factory Automation

secundary project

Melsungen for Greenfield project in Rumania

  • Creation of Process description for incoming and release testing, plant logistics, weighing & dispensing, solution preparation, filling (blow fill seal technology), visual inspection sterilization and packaging for LVP (large volume parenterals), In- process controlls (IPC).

IT & automation concept:

  • Development of automation concept and IT Infrastructure concept, creation of URS, FRA (functional risk assessments) & tender documentation, Workshop preparation and moderation, scheduling & budgeting of activities.   
bCB.Braun
10 Monate
2016-06 - 2017-03

Global MES (Manufacturing Execution System) implementation of Large Volume Parenterals (LVP) & Medical Device Disposables

Interim Project Management
Interim Project Management
  • Planning and managing of analysis, design, build and deployment phases for Pharma template, Medical Device template and ERP adapter (for SAP ECC).
  • Technical guidance on Core documentation (URSs, Validation Master Plan, GxP & ERES Assessments, Functional Risk Assessments, traceability matrix), organisation and moderation of workshops and Steering Committee meetings, development of validation concept, development and establishment of infrastructure concept for global QA, site QA and Productive systems, development and implementtion of harmonization concept for eBR (electronic btach records), MBR design training, establishment of site deployment plans for the production sites in Italy, Poland and Hana (Carribean).
Fresenius Group Bad Homburg
6 Monate
2016-07 - 2016-12

SME for global Track & Trace Implementation for CoE

secundary project

  • Setup of global Track & Trace project by definiton of core strategy, creation of Track & Trace system description, definition of IT- Infrastructure concept for all B.Braun sites, VMP (validation masterplan), Core Track & Trace URS, Functional Risk Assessment (FRA), URS for local/ site Track & Trace systems, FRA, URS for global SAP Track & Trace system (SAP ATTP), FRA, development of offline print centers for fixed layouts and variable data. 
B.Braun AG, Melsungen
6 Monate
2015-11 - 2016-04

Preparation of Core Documenation for leveraged commissioning

Validation Expert
Validation Expert

Preparation of Core Documenation for leveraged commissioning for complex Track & Trace labelling and packaging hard- and software solutions for leading Pharmaceutical companies such as Novartis, Sandoz, Bayer, BMS, Sanofi, Boehringer Ingelheim.

 

Related Equipment:

  • Flight Conveyer, Checkweigher and integrated solutions for item serialization,
  • aggregation and dis-aggregation (items to bundle to case to pallet), incl. interfaces to MLS Multiline server, SAP Aii & ATTP, MES (Werum PAS- X).    
  • Prepared, updated Configuration Matrices, Functional Specifications, Hardware Design Specifications, Validation Plans, test scenarios for System tests, FAT (factory acceptance test) testpalans, SAT (Site acceptance test) testplans and product updates of core documents for customers such as Parameter setting lists and Traceability matrices.  

 

Root Cause Analysis:

  • Supported software department in moderating root cause analysis to identify cause for data base inconsistencies, for instance time stamp errors, incorrect batch data, verified correct export of batch data from Single Unit to Multi Line Server and export to SAP Aii.

 

Impact Assessments:

  • Conducted Impact Assessments for changes, created installation procedures for software updates and associated test plans.    
Traxeed (previously Seidenader Maschinenbau Track & Trace, Munich)
11 Monate
2015-02 - 2015-12

UDI implementation, CAPA related activities

Labelling Expert
Labelling Expert

UDI implementation:

  • Identified and resolved gaps in bespoke packaging and labelling software, implemented neccessary changes due to UDI (Unique Device Identifier) requirements, created Validation Plan, updated URS, conducted FRA, created traceability matrix and required test plans for label creation software part and for label printing at packaging lines, managed IQ/ OQ and PQ with a small team, created cutover plan, trained the plant team and successfully implemented the new GAMP5 category SW version on the shopfloor.

 

CAPA related activities:

  • In parallel implemented nomenclature of product desciptions and arranged CAPA related proper translation of about 10000 items into the 25 languages of the target markets.
Zimmer Biomet GmbH, Winterthur
1 Jahr 9 Monate
2013-04 - 2014-12

commissioning and qualification of the New Solids Launch Facility

Senior QA Expert and Training Manager
Senior QA Expert and Training Manager
  • Ensured compliance to the Novartis Quality Manual and Good Manufacturing Practice of all activities related to commissioning and qualification of the New Solids Launch Facility for Novartis PharmOps covering utilities, process equipment (OSD oral solid drug manufacturing/ inhalation drug manufacturing) packaging, Plant Automation, IT Systems, Manufacturing Execution System and laboratory equipment.
  • Reviewed engineering documentation such as URSs, Functional Risk Assessments, Qualification Plans, Design documents (drawings, R&ID - process and instrumentation diagrams), Qualification Reports, IQ, OQ & PQ testplans and reports, Validtion plans and protocols to assure accordance with GMP regulations and the Novartis Quality Manual.

 

Training concept & Delivery:

  • Developed training plan and matrix according training needs of different job roles within the project, created standard operating procedure and implemented training at NSLF, mainained scheduling by LMS electronic training system and monitored training performance of all team members. 
  • Delivered classroom based GMP, Deviation handling, CAPA handling, Validation and Qualification and Testplan training.

 

Audit Program:

  • Developed and established Self- Inspection program and conducted Self Inspections as the lead auditor to drive continuous im improvements.

 

Deviation & CAPA handling:

  • Established Deviation Handling and CAPA system, conducted Root Cause Analysis and assessed impact of deviations from predetermined acceptance criteria.

 

Vendor evaluation:

  • Managed vendor selection, evaluation and CARs (ANA Audit Need Assessments, Corrective Action Requests)
OVARTIS NSLF (New Solids Launch Facility)
10 Monate
2012-09 - 2013-06

Re-engineering of compounding section

  • Successfully re- organized cleaning, sterilization and compounding section of Novartis Steriles by implementing work stations, 5S; established and executed classroom based and on the job training (OJT) and qualification of personnel in sterilization processes, compounding and filtration, established new layout of cleaning section, developed URSs for new equipment, accomplished various projects to qualify new cleaning and sterilization equipment and optimized loading schemes and recipes for autoclaves.
NOVARTIS CH Stein, Steriles
5 Monate
2012-04 - 2012-08

Implementation of ISO 13485/ development and CE marking of autoinjector device

Quality, regulatory and development related activities:

  • Established and implemented Quality Management System for Medical Devices according ISO13485 and cGMP requirements of QSR 820 CFR21 for the US market into already existing structure of the Pharmaceutical organization.
  • Created Quality Manual, top level SOPs such as Management Reviews, Design and Development, Internal Quality Audits, CAPA, Post Market Surveillance Activities and Supplier Management- established a supplier selection, evaluation, qualification and effective performance repor- ting system with KPIs, established an effective CAPA process  based on a risk evaluation matrix with adequate root cause analysis tools, CAPA plans and evaluation of effectiveness.

 

Regulatory and product development activities:

  • Support of development activities of the SUREPAL PEN drug delivery device with new drug dosis and associated documentation for 510K and CE- Marking.
SANDOZ Bio- Pharmaceuticals, Kundl, Austria
4 Monate
2011-12 - 2012-03

510 (k) PMN filing of a complex CAD/ CAM platform for dental prosthetics

  • Managed large cross functional team with various suppliers for 510 (k) PMN (premarket notification) filing of a complex CAD/ CAM platform for dental prosthetics such as crowns, copings, implants, supra structures and bridges.
  • Conducted gap analysis regarding necessary documentation for successful filing of Medical Device software with FDA “Moderate Level of Concern”, created templates and necessary documents for architectural design, Software Requirement Specifications (SRS), Software Design Specifications (SDS), Conducted risk analysis, planned and conducted verification & validation activities, performed Traceability Analysis and ensured appropriate Configuration and Life Cycle Management.

 

Update of Quality Management System (QMS):

  • Gap analysis of existing QMS, adjustment of various subsystems of organization´s Quality Management System for the new software product not covered by the existing QMS of the company
ZIMMER Dental, Carlsbad, CA
7 Monate
2011-05 - 2011-11

Adjustment of an Invitro Diagnostic (IVD) platform & successful registration of a drug/ device combinantion pruduct

  • Improvement of IVD platform for an IHC immunohisto- chemical assay, review and adoption of existing documentation and successful validation.
  • Clinical trail support, regulatory support for market release of combination product “drug/ in- vitro diagnostic” for a new indication (lung cancer NSCLC) of an existing cancer therapeutics.
MERCK SERONO, Darmstadt
1 Jahr 7 Monate
2009-10 - 2011-04

Gap assessments, development of improvement roadmaps and implementation.

Senior Consultant and Associate
Senior Consultant and Associate
  • Juran Institute, Inc. provides training, certification, and consulting services to organizations, focused on quality management including services such as lean, lean six sigma, benchmarking, problem solving, cost reduction, innovation, quality planning, quality improvement, quality control, Baldrige assessments, and continuous improvement, catering to organizations in healthcare, service providers, manufacturing, finance, automotive, education, government, and oil and gas sector.
  • Gap analysis between approach and deployment of company´s business operating system (BOS) e.g for Johnson controls within 160 plants to gain baseline, to identify weaknesses, to develop and implement QIR ( Quality Improvement Roadmap).
  • Conducted various audits as a lead auditor in electronic, interior, metal plants to analyze and score the following subsystems:
    • Management
    • Customer Firewalls
    • Product Safety Certification
    • Quality Systems
    • Supplier Quality
    • Corrective Action
    • Problem Solving, 5S/ 6S, Error Proofing
    • Standard Work
    • Kaizen
    • Tooling and Equipment
    • and Engineering Resources to identify areas for improvements, developed and success fully implemented improvement roadmaps.
Juran Institute, Southbury, Connecticut.
7 Jahre 1 Monat
2002-09 - 2009-09

Reorganization of Dentronic and preparation for implement of QMS according ISO 13483 standards

Managing Diretcor/ Partner
Managing Diretcor/ Partner
  • Dentronic was trading dental accessories and units and besides that has started to develop and manufacture devices for dental instruments. Conducted gap analysis, set a framework for the QMS, reviewed existing documentation and closed identified gaps within Device Master Files (DMRs) Device History Records (DHFs), created SOP´s, defined Quality policies, Quality management principles and objectives, Quality guidelines for each function and Q- Plans.
  • Defined processes for non- conformance and CAPA handling, defined and aligned sales, marketing, procurement, production and supporting processes (order process, personnel management, complaint handling, communications, labelling, storage & dispatch), defined and set in place performance measurement system, process measurement & analysis of quality relevant processes, trained and intro-duced QM system to employees, defined supplier selection criteria, evaluation of suppliers and type and extent of control for incoming material to meet specified requirements.
  • ISO 13485 QM System was successfully approved by LRQA, Cologne

 

New product development of dental device- control system for dental drills and scalers (rotation speed and torqueDesigned project and deliverables:

  • Work Breakdown, Gantt Chart, Activity network diagram, critical path, defined and maintained project evalution, resource management and budget.
  • Closely worked with R & D departments, head of regulatory affairs, procurement, marketing and international 

    subsidiaries of business partner of a Swiss Dental company and sucessfully developed a device for precisely controlled speed range 20 – 40000 rpm and with 1:5 contra angle up to 200000 rpm, change of rotation, torque control for dental applications such as root canal treatments, cavity preparations, gross caries removal & bone surgery with 4 preselectable speed and power levels and automatic reverse function.

  • In 2006 the ADA (American Dental Association) tested performance of dental instruments of the 8 leading manufacturers in the world and theSwiis dentral drill controlled by the Dentronic Device was the only instrument reaching pricesely the target rotation speed of 40k rpm and 200k rpm with 1:5 contra angle.

The product was launched as a package including BienAir MX mirco-motor with Dentronic “Optima T+R” control device in the US market and Europe.  

 

Developing, implementing and maintaining a Supply Chain Management system:

  • According to requirements of Quality Management System and the desire of achieving higher performance by reducing variation in the processes, better utilizing resources and more focussing on value stream reduced number of vendors and to established formal process for collecting, analyzing and reporting supplier performance. Identified and defined external customer´s requirements and needs by customer surveys, focus groups, questionnaires e.g., identified internal customer interfaces, their needs, performed gap- analysis, set improvement objectives & measurements, implemented system for tracking & reporting performance and for continuous improvement, defined and negotiated QLA.
  • Communicated product & process requirements, order & delivery requirements and safety & environmental requirements to suppliers, established supplier scorecard with metrics for PPM, accuracy, timeliness, completeness, responsiveness, return of rework, technical support given, supplier performance Cpk and supplier process Ppk to periodically compute numeric score along with total score and category labels.
  • Developed certification process to foster relationship with labelled suppliers to reduce inventory with various interim steps ( from ship to stock – JIT) to end up with modular assembly

Continuous Improvement with SIX SIGMA tool box

  • To reduce lead time to completion, to improve quality significantly and to optimize the overall performance implemented Six Sigma DMAIC- cycles in all departments of the organization ( sales, marketing, procurement, production, delivery and service). Analyzed processes and sub-processes at all levels and defined areas for improvement
  • At a very early stage reduced cycle by eliminating non value added work by simplifying and streamlining processes, reduction of unnecessary complexity, reduced motion, conveyance, overproduction, overprocessing, waiting, inventory, correction and rework.
  • Created an "As- Is" and developed a "Should- be" process map, trained and coached staff with process improvement tools for defining, measuring data, analyzing data (e.g. root cause analysis tools, cause & effects diagram, process mapping), tools for improving and control (failure mode effects analysis, Statistic Process Control), identified projects for improvements, built cross- functional teams, defined problems, developed project charter, gathe- red data, validated measurement & measurement system, determined baseline levels, baselined capability and Sigma levels, determined and quantified performance objectives, analyzed data, root causes or key factors for process variation, identified or selected solutions, defined implementation by action plans, communicated solutions to all stakeholders, implemented solutions and monitored improvements versus objectives, replicated and standardized improvements.
on request

Aus- und Weiterbildung

Aus- und Weiterbildung

1983 ? 1987

  • Johannes Gutenberg University Mainz
  • Master; Major in Communication Science, Minor in Russian and political science

Training

  • Lean Concepts, Kaizen, Kanban, Taguchi, Hoshin Planning, Quality Models &Theories: BNQP, EFQM, TQM, CQI, Leadership, Strategic Plan Development &Deployment, Quality Management Philosophies, Problem Solving Tools, Process Management Tools, Process Improvement tools, Supply Chain Management ( Supplier Selection, Ranking, Scoring, Certification), Needs Assessment Techniques and Tools, Curriculum Development &Delivery, QSIT FDA inspection techniques.  

Regulatory Agency Governance:

  • Global Regulatory Framework
  • Regulations &Guidances
  • Mutual Recognition Agreements
  • Regulatory and Health Authority Inspections
  • Enforcement Actions
  • Regulatory Agency Reporting
  • Post- Marketing Changes
  • Regulatory Reporting Requirements

Site master file (SMF) and drug master File (DMF)

Quality Systems:

  • Quality elements, QMS requirements
  • Quality Unit site Management
  • Risk Management
  • Training &Personnel Qualification ( Needs analysis/ Staff development requirements)
  • Change Control ( pre- change analysis/ Post- change analysis)
  • Investigations &CAPA ( trigger events, response actions, CAPA feedback & trending)
  • Audits &Self inspections
  • Documents &Records Management (GMP document system, GMP com-pliance records, record retention)
  • Product Quality complaints vs. adverse event reports (quality complaints, ad- verse Events &pharmacovigilance, problem response)
  • Product trend requirements
  • Supplier &contractor Quality Management ( supplier Q systems, supplier control, supplier evaluation)

Laboratory systems:

Compendia ( marketing requirements, Compendial methods review, compendial requirements review/ biological, microbiological, chemical and physical test methods)

  • Laboratory investigations of aberrant results (test data/ aberrant results)
  • Instrument control &record keeping (instrument control &calibration)
  • Specifications ( types of specifications, test data, specifications revision
  • Laboratory record keeping and data requirements ( COAs certificate of analysis), stability programs
  • Reverse samples and retrains

Infrastructure:

  • Facilities: -  Buildings
  • Manufacture &Storage environment
  • Facilities change control
  • Utilities: -  water supply systems
  • Compressed air and gas systems
  • Utility design for production
  • Utilities change control
  • Equipment: -   equipment planning/ layout/ cleaning & maintenance, validation &verification, change control

Maintenance and Metrology Systems:

  • Maintenance procedures &change control

Cleaning, sanitization and sterilization systems

Automated or computed systems:

  • Validation procedures
  • Open and closed computerized systems
  • Configuration control
  • Security requirements

Business continuity and disaster recovery planning:

  • Supply chain impact
  • Contingency plan

Materials &Supply Chain Management:

  • Incoming materials
  • Sampling process
  • Material storage, identification &rotation
  • Shipping &distribution
  • Traceability &sourcing
  • Salvaged, returned goods &destruction

Sterile and Nonsterile Manufacturing Systems

  • Filling, Packaging &labeling

Product Development &Technology Transfer:

  • Critical by design concepts (critical Quality attributes and critical process Parameters/ design space, PAT Process Analytical tools)
  • phase appropriate GMP requirements
  • raw materials and infrastructure for product development
  • new product development studies & reports scale- up and transfer activities 

 

Certification

  • ASQcertified Manager of Quality and Organizational Excellence
  • ASQcertified Six Sigma Black Belt
  • ASQcertified Biomedical Auditor
  • ASQcertified Pharmaceutical GMP Professional
  • ASQcertified Software Quality Engineer
  • NOVARTIS PharmOpscertified Trainer

Kompetenzen

Kompetenzen

Top-Skills

Manufacturing Execution Systems MES Computer Software Validation (CSV) in Regulated Industries (Pharma/ Medical Devices) Qualitätssicherung Serialization (Track & Trace) Commissioning and Qualification of Equipment Methodenvalidierung Automated Visual Inspection AVI In-Depth Root Cause Analysis IT Project Management Auditing (certified Biomedical Auditor) Quality Assurance GMP Engineering Change Projects In-vitro Diagnostics IVD Combination Products Biotechnologie Data Integrity

Produkte / Standards / Erfahrungen / Methoden

Profile

I am a Principal Consultant, ASQ certified Manager of Quality and Organizational Excellence, certified Biomedical Auditor, certified Pharmaceutical GMP Professional, certified Software Quality Engineer and Six Sigma Black Belt with more than 15 years experience in regulated industries, provided with extensive Project Management, Quality Assurance/ Compliance, Audit, Regulatory Affairs, Engineering and Vendor Management experience from medium size to large scale projects in Pharma and Medical Device industries with a strong shopfloor affinity to production processes (Pharma: Oral Solid Dosage/sterile / inhallation drug manufac-turing/ packaging; MedTech: Drug Delivery, IVD, implant/ disposables/ dental device manufacturing) as well as business processes.

Achievements in previous roles and projects:

  • Successfully managed all stakeholders as a global Pro-ject Manager at Fresenius Group SE within a global MES implementation program as part of a global SAP rollout, trained internal customers in Requirements Engineering, supported URS, ARIS process modelling, ERP adaptor and level 2 interfaces for global Pharma template (preparation, glass &blow fill for intravenous infusions) and Medical Device template for manufac-turing of disposables, defined both, infrastructure and validation concept, supported creation of VMP and crea-ted and implemented deployment plans for all 4 pilot sites.
  • Created successfully all engineering documents for B.Braun CoE for Pharmaceuticals, URS, FRA, VMP for global Track &Trace System, for Site Manager, SAP Track &Trace  and Print centres as a starting point for local site activities.  
  • Supported launch of a new, sophisticated labelling/ packaging software as a Validation Lead at Seidenader Track &Trace for item serialization and aggregation (item?case?pallet) for pharmaceutical products, created test case scenarios for FAT/ SAT to verify correct upload of batch/ material data from WERUM MES/ SAP to Muli Line Servers and line controllers and proper import of batch data to Multi Line Server/ PI Historian/ SAP Aii/ ATTP for Core Releases (Novartis/ Sandoz/ Bayer/ BI/BMS).
  • Successfully implemented UDI (Unique Device Identi-fiers) in a time critical project for 4500 implants as a Project Manager at Zimmer Biomet by adopting comprehensive software changes to label creation and printing software linked to SAP, personally revised complete documentation (URS/ FRA/ Configuration Matrix) and validated software with a small team for all lines envolved.
  • As a Senior Quality Expert at Novartis NSLF (New Solids Launch Facility/ large scale project):
    • successfully supported deployment of a GxP compliant   IT/ Automation concept, high level architecture as well as detailed design for an automated, paperless oral solid and inhalation drug (highly actives) manufacturing site with an associated laboratory integrating SAP/ PI Historian/ MES/ OPC/SCADA/LIMS.
  • Launched internal audit program and conducted self inspections as a Lead Auditor at Novartis NSLF to drive continous improvement and get prepared  for Health Authority inspections.
  • Effectively implemented and maintained training system and delivered GMP, CSV, Test plan training e.g. as Novartis NSLF Training Manager for project management team and 150 engineers.
  • Successfully ensured compliance to the Novartis Quality Manual and Good Manufacturing Practice of all activities related to commissioning and qualification of the New Solids Launch Facility for Novartis PharmOps covering utilities, all process equipment (OSD oral solid drug manufacturing/ inhalation drug manufacturing), Packa-ging, Plant Automation, Manufacturing Execution Sys-tem, and laboratory equipment. Conducted Supplier Assessments.
  • Successfully re- organized cleaning, sterilization and compounding section of Novartis Steriles as a Project/ Change Manager by implementing work stations, 5S, establishing and executing classroom based and on the job trainings and qualification of personnel in steriliza-tion processes, compounding and filtration, established new design of cleaning section, developed URSs for new cleaning equipment, accomplished various projects to qualify new cleaning and sterilization equipment and optimized loading schemes and recipes for autoclaves.
  • Successful CE marking for various class II, III Medical Devices (dental devices/ injection devices), FDA 510 (k) PMN and PMA for Medical Devices (CAD/CAM Dental Software, In- vitro Diagnostic platform, Dental Devices) as a Regulatory Affairs Consultant for Sandoz Bio Pharmaceuticals, Zimmer Dental, Merck Serono.
  • Participated in large scale improvement initiatives as a Senior Consultant of the Juran Institute Connecticut, analyzing, modeling and virtualizing production and business data to evaluate the approach and deployment of operational excellence, to identify areas for improve-ments and successfully developed and implemented Quality Improvement Roadmaps for various manufac-turing sitres in different industries.

 

I am well- provided with a sound understanding of Automation Concepts, IT infrastructure, all manufacturing and Lab processes, data requirements, analysis and utilization. 

Professional Background

2011 - today

  • Name on request
  • Owner and Principal Quality Assurance/ Compliance, Regulatory Affairs, Engineering  &Validation Consultant (manufacturing equipment/ software) 

2009 - 2011

  • Juran Associate, Connecticut, USA 
  • Senior Management Consultant, Lead Auditor
  • Plant Assessments, Development of Improvement

1988 ? 2003

  • Name on request
  • Managing Director, Incentive and Congress Management Agency

 

1983 ? 1987

  • Professional Employ-ment accompanying university studies
  • First experience in congress management at Wurzburg Congress Center, business development, sales and marketing

1979 ? 1983

  • German Army, Intelligence Service
  • Bundessprachenamt, Cologne
  • Army, Officer Special Task Force - Intelligence Service
  • 18 months intense courses in Russian and Czech level 4

Key competencies

Leadership Competency

  • Staffing, training, motivating, influencing, negotiating, KESAA, MBTI-Myers Briggs Type Indicator
  • DISC, Empowerment, Change Manage-ment, team building, team performance &evaluation.

Professional Competency

Compliance audits and performance analysis:

  • within High Level Quality Systems cGMP, GCP, GLP, GDP, GAMP5,

FDA regulation of Medical Devices:

  • QSR 21 CFR 820 Management Responsibility, Design Controls, Documentation &Change Control, Purchasing Controls, Identification and Traceability, Production &Process Controls
  • Process Validation, Cali-bration, CAPA, Packaging &Labeling Controls, Handling, Storage, Dis-tribution &Installation, Labelling, Medical Device Reporting, Recalls, Corrections &Removals
  • Device Tracking, Electronic Records and Sig-natures, In- Vitro- Diagnostic Products, Design Reviews, Risk Manage-ment, QSIT Quality System Inspection Techniques

Technical Knowledge:

  • Sterilization, Biocompatibility, Controlled Environment and Utility Systems, Software, Laboratory Testing, Environmental Monitoring: Aseptic Processing Facility design
  • Air Monitoring ( viable particulates, nonviable particulates, surface sampling, personnel monitoring, data analysis, LAL test, sterility testing, qualification &validation

 

International Standards:

  • EU Medical Directives AIMD, MDD &IVDD, International Auditing Guidelines, Regulatory Requirements, Complaint Handling
  • Capacity &Resources Management,  Process and product audits, development of Quality Improvement Roadmaps

Supply Chain Management:

  • Supplier Selection, rating, supplier performance audits &certification

Specific knowledge:

  • Dental technology management, sound knowledge of dental treatments endodontics, periodontology, implantology and restorations (Instru-ments, treatment centers, Imaging CBVT/ CLSM and CAD/ CAM and integrated solutions), In- Vitro Diagnostics (autostainer for tumor membranes, IHC, reagents, workflow parameters)
  • Oncology: biomarkers, cancer therapeutics for CLC, NSCLC, breast cancer, Combination
  • Products: drug/ IVD, regulatory requirements for Co-filing, injection devices and inhalers.
  • Plant automation systems, Manufacturing Execution systems
  • Track &Trace- Serialization &Aggregation

Methodic Competency

Environmental Analysis:

  • SWOT, Market Forces, Competitive Analysis, Benchmarking, Stakeholder Analysis, Technology Analysis, Internal Capability Analysis
  • Supplier Assessments, Customer Assessments, Legal &Regulatory Analysis

Problem Solving Tools:

  • Ishikawa, Pareto, Run-/ Control charts, Scatter Diagrams

Management Tools:

  • Affinity Diagram, AND, CPM, PERT, Gantt Chart, Interrelationship Diagraph
  • Matrix Diagram, Priorities Matrix, PDPC, Tree Diagram, RRM, LRM

Process Improvement Tools:

  • Rapid Root Cause Analysis, 5 Why´s, PDCA/ PDSA cycle, SIPOC, DFMEA/ PFMEA
  • Six Sigma DMAIC, SPC, Process Improvement Model, TOC ? Theory of Constraints

Innovation &Creativity Tools:

  • Brainstorming, Mind Mapping, Analogies, Normal Group Technique, Multi- Voting, Lateral Thinking 
  • Critical Thinking, DFSS/ DFMA, TRIZ, Story Board, Scamper

Lean Tools:

  • Cycle Time Reduction, VSM, Five ?S?, / 7 Muda ( Waste Reduction), Visual Management, Poka Yoke, Set Up/ Change over Time Reduction, TPM, Kaizen Event, Kanban, JIT, Takt Time
  • Line Balancing, Standardized Work, Single Piece Flow, Cellular Operations, CE/ SE Simultaneous Engineering, Outsourcing, Business Process Engineering

Change Management:

  • Force Field Analysis

Risk Management:

  • FMEA, FMECA, FTP, PHA, JHA, HACCP,  HAZOP

Statistics:

  • Statistic Process Control, Confidence Intervals,  Sampling, Measurement Variation Analysis, Gage R&R, Multi Vari Charts, Pugh Matrix, Conjoint analysis, DoE (Orthogonal Arrays, Fractional Fractorials, Variation Reduction &Centering of the Mean, e.g.)
  • Value Added Analysis, Statistical risks, ANOVA, ANOM, Bartlett´s, Non Parametric Tests, Hypothesis testing, FMEA- RPN, Anticipatory failure analysis, Manufacturing Controls, Correlation &Regression Analysis,, SMED, RETAD, Lot sizing.

Project Management:

  • NPV, IRR, ROI, ROA, risk analysis, feasibility assessment, WBS, AND, Critical Path Method, PERT, measurement &tracking, budget variance, EVA

Strategic Competency

  • Organizational structures, Organizational culture, Corporate-, Business- &Functional Strategies,
  • Strategic Plan Development &Deployment: Action Plans, Resource allocation and deployment, organizational performance measurement, BSC- Balanced Scorecard, Function in strategic deployment, Porter?s 5 Forces, PRESTEL, SRD (Success Resource Deployment) Generic Positioning, Outpacing Strategies, McKinsey 7-S Framework
  • Product Lifecycle Management, Target Costing/ Target Pricing, Contract Negotiation Techniques, Performance Contracting, Training Plans Aligned with Strategic Plans, Training Needs
  • Analysis, Curriculum Development &Delivery, Integrated Training Programs, Measurement &Effectiveness

Analytical Competency 

  • Business Environment Analysis: SWOT, Market Forces, Stakeholder Analysis, Technology, Internal Capability Analysis, Legal &Regulatory Analysis, Gap Analysis, Financial Analysis/financial resources, Balance Sheet, P&L Income Statement, Cashflow Analysis, non- routine analysis for special purposes, special tax issues national/ international, budget planning,Due Diligence, Product profitability, Make-or-Buy- analysis, Product/ Service cost structures, Activity based costing, Total Cost of Ownership, Return on Investment, ROA, COQ Cost of Quality, ROTI
  • Legislation: EU legislation, US legislation, Health Canada, TGA Australian Guidelines, Japan

Global Regulatory Frame work

Regulations &guidances:

MedicalDevices incl. In- Vitro Diagnostics

  • MDD:93/42/EWG, 90/385/EEC, 2007/47/EEC for AIMD, MDD, IVDD, FDA: QSR 21CFR 820

Pharmaceuticals:

  • Dir: 2001/82/EC, 2001/83/EC, 2004/27/EC
  • Reg. EC/1901/2006. EC1394/2007
  • FDA 21CFR 211/212, USDA 9CFR
  • US-Pharmacopoeia, EP, JP

Quality Assurance:

  • ISO9001, ISO13485, ISO14644, ISO17025
  • WHO- GMP, EU- GMP, FDA- cGMP, GLP, GCP, GAMP5

Regulatory inspections:

  • PAI, system- based, for-cause, license-renewal

 

Regulatory reporting:

  • Post Marketing Changes, Annual reporting
  • 21CFR 314, subpart H/ 21CFR 601, subpart E

                 

Mutual Recognition

Agreements:

  • ICH, PIC/s, IPEC

IT Competency Software

  • Software Quality Management, Systems &Software engineering processes, system architecture, Requirements Engineering (Caliber/ Silk, e.g.), Software Metrics and Analysis, Configuration Management, Risk Management, Reviews &Inspections, Software Validation
  • Software audits, Data Analysis, modelling and virtualization (JBoss, e.g.), integration of data sources SAP Aii, SAP R/3, PI Historian, MLM/MLS, MES, LIMS, OPC, SCADA.

International Intercultural´Competency

  • More than 20 years experience and deep knowledge of ethnics, mentalities and culture in dealing with business partners, officials, government organizations in ASIA, North America, Latin America, Middle East, Africa, Russia, CIS and Europe, strong problem solving abilities, even in critical situations.

 

Soft Skills

  • results driven, logical and methodical approach achieving tasks and objectives
  • excellent analytical, organizational and leadership skills
  • effective and open communication at all levels/ with all interfaces, confident and persuasive
  • excellent problem solving abilities
  • empathic: facilitator and enabler
  • highly motivated to overcome hurdles and constraints to make good things better

Strengths:

  • I have strong analytical, project management and communication skills as well as a comprehensive background of root cause analysis and process improvement tools, in depth knowledge of global Medical Device and Pharmaceutical Quality System requirements, regulatory strategies, Quality System Inspection techni-ques and production processes and equipment in both industries including GMP compliant equipment qualification and process validation standards. 
  • I am used to work within complex scenarios asking for strong analytical, excellent planning, problem solving, communication and execution abilities.       

Branchen

Branchen

  • Medical Device Industry: dental and surgical instruments, implants, Invitro- diagnostics, CAD/ CAM software for dental restorations, drug delivery devices
  • Pharmaceuticals Industry: Aspetic processing, oral solid and inhalation drug manufacturing, packaging and labelling, process analysis, process validation and equipment qualification, Lab processes and euipment, batch data analysis, Deviation &CAPA handling

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