Projektleitung, Auditierung, Prozessoptimierung, etc. in der Med.-Tech und Pharma
Aktualisiert am 29.05.2024
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Verfügbar ab: 29.05.2024
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Senior-Berater
Auditor
Managementberatung
Mergers & Aquisitions
Due-Diligence-Prüfung
Integrationsmanagement
Qualitätsmanagement (Einführung...)
Prozessmanagement
Business Development
Managementerfahrung
Good Manufacturing Practice
Good Distribution Practice
Good Documentation Practice
Healthcare
Risikomanagement
FMEA
German
Fluent
English
Fluent

Einsatzorte

Einsatzorte

Freilassing (Deutschland) (+500km) Seewalchen am Attersee (+500km)
Deutschland, Österreich
Ich bin grundsätzlich in ganz Deutschland und Österreich aktiv, sowie auch in anderen, internationalen Standorten,
möglich

Projekte

Projekte

9 Monate
2023-09 - heute

Support the 2 local Quality Assurance Teams

Quality Systems Remediation Engineer/Training- and Integration- Support
High Risk, Implantable Medical Devices (North Rhine Westfalia, Germany and Multiple Sites, East Coast, USA)
  • Support the 2 local Quality Assurance Teams during the ongoing Integration (Post Acquisition Phase) in Germany and USA
  • Support the Training-Department in managing the ILT-Trainings and the different Training Tools (e.g. Compliance Wire)
  • Provide support during Corrective and Preventive Action (CAPAs) activities and manage the CAPA system.
  • Support moving NCs, CAPAs, Complaints and Audits into the new corporate IT systems.
  • Review and update the existing Supplier Quality Agreements against regular and/or corporate standards
  • Partner with Process owners to generate and metrics, which reflect the health of different Quality System elements.
  • Ensure compliance of the existing /and partially in transit) QMS through authoring and updating Standard Operating Procedures (SOP).
  • Organize, prepare, and lead weekly/bi-weekly project progress meetings with the stakeholders and ensure progress is consistently communicated to other internal partners.
  • Provide support during Internal- / PAA-Audits and External audits such as 
  • Notified Body and Competent Authority Audits, including follow-up on actions:
    • Train the local employees in audit behaviour and readiness
1 Jahr 3 Monate
2023-03 - heute

Marketing- and Benchmarking Audits

Field Analyst, Freelance, Germany and Austria
Field Analyst, Freelance, Germany and Austria
  • Marketing- and Benchmarking Audits within the pharmaceutical environment
    • § KPI Collection and detailed global Reporting
  • Monitoring and evaluation of Roleplays within the pharmaceutical environment
global acting and leading Pharmaceutical and Life Science Company
3 Monate
2023-07 - 2023-09

MDR- and FDA-Readiness - Check (Upper Austria, Austria)

Senior Quality Engineering & Project Support
Senior Quality Engineering & Project Support
  • Perform a ?Worst-Case-Audit? including: (Extract)
    • Review the ongoing Product- / Manufacturing Transfer activities against the requirements and regulations to ensure the full compliance (internal and external requirements) before and during first MDR-Audit and planned FDA-Inspection
    • Stress / challenge the employees? behavior and their Audit-Management
    • Review Supplier-related Documentation (Changes, Non-Conformities, 8D-Reports, Risk-Files and Incoming Inspection documents
    • Review Status of:
  • Quality- and Risk- Management,
  • Batch Records,
  • Complaint Handling, NC- /CAPA-Management,
  • Preventive Maintenance and EHS-Management
  • Decommissioning of the local site
    • Checking all the relevant internal and supplier related documents against former Audit-Findings to ensure full compliance during the upcoming external audit
Medical Devices
3 Monate
2023-04 - 2023-06

Responsibility for compliance with the specified quality standards

Interim Quality Manager (illness representation)
Interim Quality Manager (illness representation)
  • Leading a team of 15 quality employees
  • Responsibility for compliance with the specified quality standards
  • Testing/control and consistent response in the event of non-compliance with quality specifications
  • Accompaniment or further development of the entire manufacturing process
  • Ensuring and controlling compliance with occupational safety, GMP and multiple quality standards
  • Continuous development of the Integrated Management System in the area of quality at the site including change control management, validation / qualification, quality cycle and continuous improvement
  • Management of internal audits including control of 5S program, cleanliness and order in the work area
  • Responsibility for the processing of customer complaints
Pharmaceuticals (Ampoules and Vials) (Baden Wuerttemberg, Germany)
2 Jahre 2 Monate
2021-01 - 2023-02

Global Corporate Integration Project

Senior Quality Engineering & Project Lead
Senior Quality Engineering & Project Lead
Medical Devices: Global Corporate Integration Project (Germany and Switzerland plus 5 Sites in France, Ireland and U.S.A.)
  • Project Coordinator:
    • Integration of Corporate Quality System at 5 acquired Sites.
    • Create and Maintain Site-Based Quality Integration Plans
    • Update the Legacy Quality System into EU-MDR- Ready Status
    • Aligned Remediation Approach with different Workstreams (Risk Management, Engineering, Manufacturing, R&D)
    • KPI reporting and communication with M&A-Team and other Stakeholder
    • Preparation / Support of EU-MDR- Audits and FDA-Inspections
  • Integration / Remediation Support:
    • Update of Risk Related Documents (RMF, RMR, FMEA´s) against Global Corporate- and EU-MDR - requirements.
    • Update of the Inspection- and Control-Plans
    • Initiate Non-Conformance- / PMS- Activities:
      • CAPA coordination (for internal and external findings) and ensure proper remediation.
      • Include NC/CAPA/Complaints/Scrap Rates/Trends into Remediations and Corrective Activities
    • Support Updates of SOP´s, WI´s, etc.
    • Provide guidance and training for implementation of robust structures on the integrated and remediated activities.
    • Audit-Training
Medical Devices
1 Jahr 10 Monate
2019-03 - 2020-12

M&A Integration Project (Israel)

Senior Quality Engineering & Project Management
Senior Quality Engineering & Project Management
Project Coordinator:
  • Confirm Due Diligence Results and asses the State of Compliance of the Quality System versus Internal (Corporate) and Regulatory Standards (ISO, FDA, etc.)
  • Close reporting to local Core Team Leads and global M&A-Leader
  • Prepare Manufacturing Transfer from Israel to European Sites of the acquiring Corporation.


Project Support:

  • Audit existing procedures and documents to the standards and report non-conformances and findings (both current state and retrospectively):
    • Analyzing of Audit- and Inspection reports (Internal / External), NC/CAPA-Files, Complaints and Complaint Handling, Maintenance Reports, Monitoring Data, Trainings, etc.
    • Perform CAPA verification of effectiveness and add activities as necessary.
    • Batch record review
  • Update the Manufacturing- and Quality System to meet the Corporate Standards
  • Update the Health and Safety System to meet local, international and Corporate Requirements
  • Update the Complaint Handling System to reduce the runtime and ensure a compliant communication to the involved authorities
  • Make recommendations to achieve compliance where shortfalls are found and identify improvement potentials, which increase the productivity and efficiency of manufacturing and facility and operational practices.
  • Training ? Support:
    • FDA Preparation (1st time FDA-Audit in the Company)
    • Support during the FDA inspection
    • Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
    • Consultancy and guidance of all employees regarding Risk Assessment, Risk Analysis, Maintenance, NCR, CAPA, Complaint-Handling, etc
    • GCP, GVP, GMP, cGMP, GDP etc.
  • Planning, implementing, follow up projects of
    • Pest Control
    • Fatigue Testing
    • Preventive Maintenance
    • Launching Product in the US
Medical Device (Coated / Resorbable)
2 Jahre 5 Monate
2016-10 - 2019-02

complete Site Decommissioning (Austria)

Interim Deputy of Site Quality Lead (during Site Closure)
Interim Deputy of Site Quality Lead (during Site Closure)
Project Coordinator:
  • Coordinate the Manufacturing Transfer during Site Closure with local (Austria), European (Switzerland, Germany) and Global (U.S.A.) Sites and Leaders
  • Coordinate the structured Archiving of all Manufacturing- and Quality related Documents and Records into a Swiss Archive
  • Tracking of Deadlines and Meeting with local and corporate Management 


Project Support:

  • Support ongoing Product- / Manufacturing Transfer activities to ensure the full compliance (internal and external requirements) until full closure 
  • Taking over continuously more activities for continuously reducing internal employees:
    • Quality Management,
    • Complaint Handling,
    • CAPA-Management,
    • EHS-Management and
    • Doc. Control incl. Record Management and Archiving
  • Checking all the relevant internal and supplier related documents against former Audit-Findings to ensure full compliance during ongoing external audits until site-closure
  • Prepare and Lead Quality related Meetings:
    • Monthly Management Reviews
    • Ongoing NC/CAPA- and Complaint-Status Meeting
  • Coordination and Support of ongoing Activities incl. newly found Complaints, Manufacturing Investigations and Corrective / Preventive Activities
  • Audit Preparation and Supporting Mock Audit
  • Support the controlled and structured Hand-Over of the Site at its last day
Medical Device
5 Monate
2016-06 - 2016-10

FDA-Readiness Check (especially regarding Narcotics) (Southern Germany)

Senior Quality Engineering & Project Support
Senior Quality Engineering & Project Support

Project Coordinator

  • Assess the current status against previous FDA- and Notified Body-Findings
  • Identify urgently needed activities before the FDA-Audit is taking place
  • Plan and Support Remediations


Project Support:

  • Support the ongoing Updates of SOP´s / Engineering Documents / Risk Management Files (incl. Focus on requirements for Narcotics)
  • Review and optimize the Traceability of Products
  • Finish the open Complaint Handling activities
  • Preparation the Audit (incl. ?Behavior-Training?)
Pharmaceuticals
5 Monate
2016-01 - 2016-05

Prepare Re-Certification of Orthopedic / Trauma Implants and Combination Products (Austria)

Senior Quality Engineering & Audit Support
Senior Quality Engineering & Audit Support
Project Support:
  • Review and Update related Quality Documents
  • Review and support ongoing activities for NC/CAPA´s and Customer Complaints
  • Support needed Supplier Audit
  • Perform internal ?Worst Case?-Audit (Role as a ?Worst-Case?-Auditor)
  • Trainings local Management in Audit Topics
Medical Devices
10 Monate
2015-03 - 2015-12

Orthopedic / Trauma / Sports Med Implants and Instruments (Southern Germany and Switzerland)

Senior Quality Engineering & Project Support
Senior Quality Engineering & Project Support
Project Support:
  • Support the local Project Managers and Coordinate a structured Remediation between 3 Sites
  • Support the Change of the complete Product Portfolio (sterile and non-sterile) to UDI (Unique device identification) Compliant Labels
    • Affected products: Sterile Implants, Single-Use, Injectable cements and artificial bone, antibiotic coatings, BMPs
  • Update the internal SOP´s and WI´s to ensure a compliant creation and inspection of UDI-conforming Barcodes and Human readable Information on Labels
  • Point of Contact for all external suppliers and internal worldwide divisions regarding UDI
  • Review ongoing and newly created NCR´s/CAPA´s and Complaints against Labeling / Traceability Issues and implement appropriate Corrections and Remediations
Medical Devices
2 Monate
2015-01 - 2015-02

FDA-Readiness - Final Check (Austria)

Senior Quality Engineering & Project Support
Senior Quality Engineering & Project Support
Project Support:
  • Assess the current status against previous FDA- and Notified Body-Findings
  • Review closed activities before the FDA-Audit is taking place
  • Support the last ongoing Updates of SOP´s / Engineering Documents / Risk Management Files
  • Support finishing the open Complaint Handling activities
  • Preparation the Audit (incl. ?Behavior-Training?)
Medical Devices
1 Jahr 5 Monate
2013-08 - 2014-12

Global FDA Remediation Project

Project 2

Improvement of Processes, Documentation and Sterility Assurance for Implants
and Instruments of the newly created Loaner Department (Switzerland)


Project Support:

  • Support for new Loaner Department:
    • Designing new SOPs
    • Setting up a new Quality System acc. Corporate Standards on-site
    • Quality Agreements against updates needed for the new site
    • Establishing a new Training System for new employees
  • Review legacy documentation for improving the Loaner System
    • Perform Complaint- and CAPA-Reviews
    • Review Scrap- and Review-Rates
  • Support Certification:
    • Preparing for final internal (Corporate-) Audit and ISO Certification
    • Support closure of TÜV-Findings of ?Sister-Sites?
    • Preparation of FDA-Audit


Project 1:

Review of Documentation (DHRs), Archiving System and Sterility Assurance
Remediations for Implants and Instruments against FDA- and TÜV-Findings and
establish appropriate Remediation activities.
(Switzerland, Austria and Germany)


Project Support:

  • Determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.) to Core Team - / Workstream- Leads
  • Audit site related procedures to the standards and report out on findings (both current state and retrospectively) in different sites in Switzerland, Austria and Germany.
    • Provide Audit reports as directed to the local, European and US-Management.
    • Make recommendations to achieve compliance where shortfalls are found.
    • Review and Support of Dose Mappings and Dose Audits and Review documentation of Supplier
    • Review the Validation of Gamma Irradiation - Sterilization
    • Optimize the Pest Control System at 2 Manufacturing Sites
    • Support the Cleaning Validation, Cleanroom Qualification, and ?Water?-Validation
  • Analyzing and Supporting Activities:
    • Perform root cause analysis and corrective / preventive actions for CAPAs as necessary.
    • Perform CAPA verification of effectiveness as necessary.
    • Analyzing NCR- and CAPA files.
    • Analyzing inspection activities.
    • Analyzing maintenance reports and monitoring data.
  • Bringing in of improvement proposals, which increase the productivity and efficiency of manufacturing and facility and operational practices.
    • Consultancy and guidance of all employees regarding maintenance, NCR, CAPA etc.
    • Support Internal Audit
  • Improve the local archiving activities to prevent similar failures in the future
Medical Devices, Switzerland, Germany and U.S.A.
1 Jahr 5 Monate
2013-05 - 2014-09

Quality Engineering & Project Support

Project Support:
  • Support in upgrading the Quality Management (SOPs, Training)
  • Preparation for FDA Submission and Audit
    • focus: Complaints, CAPA, Risk Analysis, Health and Safety Environment, Field Alerts and Actions, etc.)
  • Implementation of a Product Management
  • Implementation of a Supplier Management
  • Support in Technical documents / DMFs for Products: BMPs, vascular grafts
  • Affected products: BMPs, Vascular Grafts, Bone Grafts, Antibiotics, Aseptic productions
R&D company for Pharmaceutical Coatings and Innovative Products, Germany
1 Jahr
2013-01 - 2013-12

Quality Engineering and Interim Management

Project Support:
  • Interim support for the International Product- and Sales Manager
  • Support in the Quality Management (CAPA, Complaints, Risk Analysis, etc.)
  • Training of customers and distributors (worldwide)
  • Initializing and support of studies for international market approvals (FDA, SFDA, CE)
  • Affected products: Hyaluronic Acid, Aseptic production, Injectable
Manufacturer of Hyaluronic Acid, Germany and China
10 Monate
2012-10 - 2013-07

Quality Engineering & Project Support

Project Support:
  • Installation of a complete Quality Management System for Trauma Implants and Instruments (according to ISO 13485) including SOPs, Development procedures, CAPA-System, Complaint Handling, etc. and monitoring of the market approvals,
  • Implementation of a Product Management
  • Training of external suppliers
  • Implementation of a HSE-System
  • Support in the market approval procedures (CE-Mark)
  • Affected products: Sterile Implants
Manufacturer of Medical Devices, Germany and Poland

Aus- und Weiterbildung

Aus- und Weiterbildung

4 Jahre 3 Monate
2005-09 - 2009-11

Studie Health Care Management (?Gesundheitswesen ? Technische Medizinwirtschaft?)

Diploma in Health Care Economics (Dipl. Ges. Oec.), University of Applied Science (Hochschule Niederrhein), Krefeld
Diploma in Health Care Economics (Dipl. Ges. Oec.)
University of Applied Science (Hochschule Niederrhein), Krefeld

  • medical controlling
  • hospital management
  • health economics and reimbursement
  • Diploma thesis: on Request


2 Jahre
1997-10 - 1999-09

Medical School

Medical School, University ? Gesamthochschule Essen
Medical School, University ? Gesamthochschule Essen

1 Jahr 7 Monate
1995-06 - 1996-12

Training for Emergency-Medical-Paramedics

School of Paramedics, Klinikum Niederberg, Velbert/ Fire department, City of Essen
School of Paramedics, Klinikum Niederberg, Velbert/ Fire department, City of Essen

9 Jahre
1986-07 - 1995-06

Higher School Certificate (Abitur)

Higher School Certificate (Abitur), Geschwister-Scholl-Gymnasium, Velbert
Higher School Certificate (Abitur)
Geschwister-Scholl-Gymnasium, Velbert

Position

Position

  • CEO / Senior Consultant / Interim Management (Pharm.& Med. Device / Automotive)
  • QM/ QA/ GMP/ cGMP / GCP / GDP / Regulatory/ Compliance in Medical Devices and Pharmaceutical Companies
  • Project Management
  • Due Diligence- and M&A-Support
  • Integration and Decommissioning- Support
  • Global Remediations
  • FDA Readiness
  • Auditor for ISO & MedDevs / Batch Records and Technical Documentation / EHS-Manager

Kompetenzen

Kompetenzen

Top-Skills

Senior-Berater Auditor Managementberatung Mergers & Aquisitions Due-Diligence-Prüfung Integrationsmanagement Qualitätsmanagement (Einführung...) Prozessmanagement Business Development Managementerfahrung Good Manufacturing Practice Good Distribution Practice Good Documentation Practice Healthcare Risikomanagement FMEA

Produkte / Standards / Erfahrungen / Methoden

METHODICAL EXPERIENCE (EXTRACTS)

1999 - today

Auditing and Training (Automotive, MedDev, Pharma):

  • Internal and External Audit-Support
  • Preparation, Execution and Support with Internal Audits, Supplier Audits, External Audits (for NBs and Customers) and Worst Case Assessments
  • Perform Trainings (incl. Behaviour Training for Employees)
  • Benmarking Audits and Field Visits


2001 - today

Pharmaceutical- and Medical Device Industry specific

Certification Support (Product Related):
  • Support Submission Process
    • Perform Conformity Assessments
    • Create and update relevant files / Tech Docs
  • Communication with Authorities before, during and after Submissions


Communications with relevant Authorities:

  • FDA, BSI, AGES, BfArM, Swiss Med, ANVISA, Notified Body, BGs, AUVA, etc.


Contracts / Agreements:

  • Quality Agreements
    • incl. Design and implementation of APR/APQR
  • URS


Doc. Control:

  • Creation / Implementation, Maintenance and Update of Quality Systems and Documents
  • DHR / Master Records and Batch Reviews
  • GDP Trainings


Due Diligence and M&A-Support

  • Support and perform initial Assessments
  • Full Integration Support
  • Perform Decommissioning Activities


EHS / Health and Safety Management

  • Support as Internal (Interim) or External Safety Manager


GXP-Support

  • GMP, cGMP, GCP, GDP, etc.


Marketing

  • Market Research / New Markets / Business Development
  • Reimbursement (e.g. DRG)
  • Pre- and Post-Assessments and Activities
    • incl. Benchmarking


Post Market Surveillance / Vigilance Systems:

  • Establishment and execution of Field Alerts and Escalation process
  • Creation and Executions of CAPA´s, NCR´s and Deviations
  • Complaint-Handling
  • Support Recalls and Field Actions incl. relevant communications with Authorities (incl. Recall- and Complaint-Handling-Trainings)


Project Management

  • incl. Intervention-Support


Product Management

  • incl. Sales Support
    • User and Customer Trainings


Production / Manufacturing

  • Calibration Activities
  • Labeling, UDI (EU/FDA) and TrackAndTrace (Pharma)
  • Manufacturing Transfer
  • Preventive Maintenance
  • Validation, Verification and Qualification Activities:
    • Plannings and Documentation (Master Plans, Reports, etc.)
    • Qualification/Validation according to ICH-Guidelines
  • Validation / Gamma Irradiation ? Sterilization


Regulatory

  • Internal and communication with Authorities
  • RA-Files Support
    • incl. specific requirements for Narcotics and Oncologics
  • Field Action- and Recall Management


Risk Management

  • Creation and Updates of Risk Files (RMFs, FMEAs, etc.)
  • Risk- and Gap-Assessments
    • RM-Techniques (e.g. 5-Why, FaultTree, Fisbone, etc.)

Standards, Regulations and Guidelines (Extracts)
  • ISO 9001; ISO 10993-1; ISO 13485; ISO 14155-1 and 14155-2; ISO 15225; ISO 15378, ISO 17025; ISO 19011; 21 CFR 820; CMDCAS; ICH Q9, Q10; TR 24971; IEC 62971, EU Phr., ISO 4806-1/-2 
  • 2017/745 (EU MDR) ; 93/42/EEC (MDD); 90/385/EEC (AIMD); 2017/746 (EU IVDR); 98/79/EC (IVDD) 
  • EU Phr., USP

PROFESSIONAL EXPERIENCE

2013 - today
Role: Founder Member of DIN EN 15224-Competence-Network

2011 - today
Role: Certified EHS Manager (?SIFA? or ?FASI?)
Customer:  Verwaltungs-Berufsgenossenschaft, Germany (2011) and WiFi, Austria (2020)

10/2008 - today
Role: CEO (and Founder) 
Customer: on Request

Tasks:
  • Development, Implementation and Upgrade of Management-Systems (e.g. Quality, Risk, HSE, Environment)
  • Trainings and Courses (e.g. Emergency-Trainings)
  • Services / support in
  • Optimization of health and safety / Emergency-Management
  • Optimization of working processes
  • Product- and Interim management
  • Approval of Medical Devices
  • Attending of Clinical Studies
  • External Auditor (for different certifying companies and Notified Bodies)
  • External Health and Safety Manager
  • Expert for Medical Devices (for different Notified Bodies)

2011 - 2015
Role: External Expert for Quality Management and Medical Devices
Customer: mdc ? medical device certification GmbH, Stuttgart

2010 - 2015
Role: External Expert / Auditor (ISO 9001, 13485 and MDD active/non active, technical documentation)
Customer: TUEV Nord Cert GmbH, Essen

07/2006 ? 09/2008

Role: Product Manager Spine und Biomaterials
Customer: Clinical House GmbH, Bochum / Synthes, Oberdorf (Switzerland)

Tasks:
  • Responsible PM for Cervical Spine und all Biomaterials
  • Quality manager for the existing DIN EN ISO 9001 und 13485 certifications
  • Support and Evaluation of clinical studies for the approval of new products
  • Closure of the company at 30.09.2008

07/2003 ? 06/2006
Role: Territorial Manager for Northern Germany (Niedersachsen, Bremen, Schleswig-Holstein, Hamburg and Mecklenburg-Vorpommern)
Customer: ZOLL Medical Deutschland, Cologne

Tasks:
  • Responsible for all products (defibrillators, resuscitation products, Volume-Therapy (Military) und Quality management
  • Support and Evaluation of clinical studies for the approval of new products and the upgrade of existing products (In German hospitals, ground- and air-based Emergency Medical Services) in co-operation with the U.S. headquarter

07/2001 ? 06/2003
Role: Paramedic and Trainer
Customer: Johanniter-Unfall-Hilfe (St. Johns), Ortsverband Stedingen / Weser-Ems

Tasks:
  • Responsible for the Emergency Medical Service und Training of the personnel
  • Co-operation with Medical Device Companies (testing new products and market evaluations, etc.)

01/2001 ? 06/2001

Role: aramedic (Air and Ground) and Trainer

Customer: Berufsfachschule für den Rettungsdienst , incentiveMED, Erbach (Odw.)

04/1996 ? 12/2000
Role: Paramedic and Trainer

Customer: Berufsfeuerwehr and Malteser, Essen


TECHNICAL EXPERIENCE EDV-SOFTWARE

  • Software- / ERP- / Doc. Control- Systems
    • SAP
    • VFlow
    • Filemaker
    • AGILE
    • EtQ
    • TrackWise
    • VEEVA Quality Suite
  • Conference Tools:
    • TEAMS, WebEx, ZOOM, FaceTime, CISCO, etc.
  • Windows and MS-Office Tools:
    • Word, Excel, PowerPoint, MS-Visio, MSProjects, Office 365 1995 Advanced
  • Apple OS and Tools:
    • iWorks (Apple own ?Office? solution)
    • IOS, iPadOS, WatchOS and MacOS

Branchen

Branchen

  • Automotive (2009)
  • Pharmaceutical Industry (2006)
  • Medical Devices Industry (2003)
  • Emergency Medical Service / Hospital (1995)

Einsatzorte

Einsatzorte

Freilassing (Deutschland) (+500km) Seewalchen am Attersee (+500km)
Deutschland, Österreich
Ich bin grundsätzlich in ganz Deutschland und Österreich aktiv, sowie auch in anderen, internationalen Standorten,
möglich

Projekte

Projekte

9 Monate
2023-09 - heute

Support the 2 local Quality Assurance Teams

Quality Systems Remediation Engineer/Training- and Integration- Support
High Risk, Implantable Medical Devices (North Rhine Westfalia, Germany and Multiple Sites, East Coast, USA)
  • Support the 2 local Quality Assurance Teams during the ongoing Integration (Post Acquisition Phase) in Germany and USA
  • Support the Training-Department in managing the ILT-Trainings and the different Training Tools (e.g. Compliance Wire)
  • Provide support during Corrective and Preventive Action (CAPAs) activities and manage the CAPA system.
  • Support moving NCs, CAPAs, Complaints and Audits into the new corporate IT systems.
  • Review and update the existing Supplier Quality Agreements against regular and/or corporate standards
  • Partner with Process owners to generate and metrics, which reflect the health of different Quality System elements.
  • Ensure compliance of the existing /and partially in transit) QMS through authoring and updating Standard Operating Procedures (SOP).
  • Organize, prepare, and lead weekly/bi-weekly project progress meetings with the stakeholders and ensure progress is consistently communicated to other internal partners.
  • Provide support during Internal- / PAA-Audits and External audits such as 
  • Notified Body and Competent Authority Audits, including follow-up on actions:
    • Train the local employees in audit behaviour and readiness
1 Jahr 3 Monate
2023-03 - heute

Marketing- and Benchmarking Audits

Field Analyst, Freelance, Germany and Austria
Field Analyst, Freelance, Germany and Austria
  • Marketing- and Benchmarking Audits within the pharmaceutical environment
    • § KPI Collection and detailed global Reporting
  • Monitoring and evaluation of Roleplays within the pharmaceutical environment
global acting and leading Pharmaceutical and Life Science Company
3 Monate
2023-07 - 2023-09

MDR- and FDA-Readiness - Check (Upper Austria, Austria)

Senior Quality Engineering & Project Support
Senior Quality Engineering & Project Support
  • Perform a ?Worst-Case-Audit? including: (Extract)
    • Review the ongoing Product- / Manufacturing Transfer activities against the requirements and regulations to ensure the full compliance (internal and external requirements) before and during first MDR-Audit and planned FDA-Inspection
    • Stress / challenge the employees? behavior and their Audit-Management
    • Review Supplier-related Documentation (Changes, Non-Conformities, 8D-Reports, Risk-Files and Incoming Inspection documents
    • Review Status of:
  • Quality- and Risk- Management,
  • Batch Records,
  • Complaint Handling, NC- /CAPA-Management,
  • Preventive Maintenance and EHS-Management
  • Decommissioning of the local site
    • Checking all the relevant internal and supplier related documents against former Audit-Findings to ensure full compliance during the upcoming external audit
Medical Devices
3 Monate
2023-04 - 2023-06

Responsibility for compliance with the specified quality standards

Interim Quality Manager (illness representation)
Interim Quality Manager (illness representation)
  • Leading a team of 15 quality employees
  • Responsibility for compliance with the specified quality standards
  • Testing/control and consistent response in the event of non-compliance with quality specifications
  • Accompaniment or further development of the entire manufacturing process
  • Ensuring and controlling compliance with occupational safety, GMP and multiple quality standards
  • Continuous development of the Integrated Management System in the area of quality at the site including change control management, validation / qualification, quality cycle and continuous improvement
  • Management of internal audits including control of 5S program, cleanliness and order in the work area
  • Responsibility for the processing of customer complaints
Pharmaceuticals (Ampoules and Vials) (Baden Wuerttemberg, Germany)
2 Jahre 2 Monate
2021-01 - 2023-02

Global Corporate Integration Project

Senior Quality Engineering & Project Lead
Senior Quality Engineering & Project Lead
Medical Devices: Global Corporate Integration Project (Germany and Switzerland plus 5 Sites in France, Ireland and U.S.A.)
  • Project Coordinator:
    • Integration of Corporate Quality System at 5 acquired Sites.
    • Create and Maintain Site-Based Quality Integration Plans
    • Update the Legacy Quality System into EU-MDR- Ready Status
    • Aligned Remediation Approach with different Workstreams (Risk Management, Engineering, Manufacturing, R&D)
    • KPI reporting and communication with M&A-Team and other Stakeholder
    • Preparation / Support of EU-MDR- Audits and FDA-Inspections
  • Integration / Remediation Support:
    • Update of Risk Related Documents (RMF, RMR, FMEA´s) against Global Corporate- and EU-MDR - requirements.
    • Update of the Inspection- and Control-Plans
    • Initiate Non-Conformance- / PMS- Activities:
      • CAPA coordination (for internal and external findings) and ensure proper remediation.
      • Include NC/CAPA/Complaints/Scrap Rates/Trends into Remediations and Corrective Activities
    • Support Updates of SOP´s, WI´s, etc.
    • Provide guidance and training for implementation of robust structures on the integrated and remediated activities.
    • Audit-Training
Medical Devices
1 Jahr 10 Monate
2019-03 - 2020-12

M&A Integration Project (Israel)

Senior Quality Engineering & Project Management
Senior Quality Engineering & Project Management
Project Coordinator:
  • Confirm Due Diligence Results and asses the State of Compliance of the Quality System versus Internal (Corporate) and Regulatory Standards (ISO, FDA, etc.)
  • Close reporting to local Core Team Leads and global M&A-Leader
  • Prepare Manufacturing Transfer from Israel to European Sites of the acquiring Corporation.


Project Support:

  • Audit existing procedures and documents to the standards and report non-conformances and findings (both current state and retrospectively):
    • Analyzing of Audit- and Inspection reports (Internal / External), NC/CAPA-Files, Complaints and Complaint Handling, Maintenance Reports, Monitoring Data, Trainings, etc.
    • Perform CAPA verification of effectiveness and add activities as necessary.
    • Batch record review
  • Update the Manufacturing- and Quality System to meet the Corporate Standards
  • Update the Health and Safety System to meet local, international and Corporate Requirements
  • Update the Complaint Handling System to reduce the runtime and ensure a compliant communication to the involved authorities
  • Make recommendations to achieve compliance where shortfalls are found and identify improvement potentials, which increase the productivity and efficiency of manufacturing and facility and operational practices.
  • Training ? Support:
    • FDA Preparation (1st time FDA-Audit in the Company)
    • Support during the FDA inspection
    • Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
    • Consultancy and guidance of all employees regarding Risk Assessment, Risk Analysis, Maintenance, NCR, CAPA, Complaint-Handling, etc
    • GCP, GVP, GMP, cGMP, GDP etc.
  • Planning, implementing, follow up projects of
    • Pest Control
    • Fatigue Testing
    • Preventive Maintenance
    • Launching Product in the US
Medical Device (Coated / Resorbable)
2 Jahre 5 Monate
2016-10 - 2019-02

complete Site Decommissioning (Austria)

Interim Deputy of Site Quality Lead (during Site Closure)
Interim Deputy of Site Quality Lead (during Site Closure)
Project Coordinator:
  • Coordinate the Manufacturing Transfer during Site Closure with local (Austria), European (Switzerland, Germany) and Global (U.S.A.) Sites and Leaders
  • Coordinate the structured Archiving of all Manufacturing- and Quality related Documents and Records into a Swiss Archive
  • Tracking of Deadlines and Meeting with local and corporate Management 


Project Support:

  • Support ongoing Product- / Manufacturing Transfer activities to ensure the full compliance (internal and external requirements) until full closure 
  • Taking over continuously more activities for continuously reducing internal employees:
    • Quality Management,
    • Complaint Handling,
    • CAPA-Management,
    • EHS-Management and
    • Doc. Control incl. Record Management and Archiving
  • Checking all the relevant internal and supplier related documents against former Audit-Findings to ensure full compliance during ongoing external audits until site-closure
  • Prepare and Lead Quality related Meetings:
    • Monthly Management Reviews
    • Ongoing NC/CAPA- and Complaint-Status Meeting
  • Coordination and Support of ongoing Activities incl. newly found Complaints, Manufacturing Investigations and Corrective / Preventive Activities
  • Audit Preparation and Supporting Mock Audit
  • Support the controlled and structured Hand-Over of the Site at its last day
Medical Device
5 Monate
2016-06 - 2016-10

FDA-Readiness Check (especially regarding Narcotics) (Southern Germany)

Senior Quality Engineering & Project Support
Senior Quality Engineering & Project Support

Project Coordinator

  • Assess the current status against previous FDA- and Notified Body-Findings
  • Identify urgently needed activities before the FDA-Audit is taking place
  • Plan and Support Remediations


Project Support:

  • Support the ongoing Updates of SOP´s / Engineering Documents / Risk Management Files (incl. Focus on requirements for Narcotics)
  • Review and optimize the Traceability of Products
  • Finish the open Complaint Handling activities
  • Preparation the Audit (incl. ?Behavior-Training?)
Pharmaceuticals
5 Monate
2016-01 - 2016-05

Prepare Re-Certification of Orthopedic / Trauma Implants and Combination Products (Austria)

Senior Quality Engineering & Audit Support
Senior Quality Engineering & Audit Support
Project Support:
  • Review and Update related Quality Documents
  • Review and support ongoing activities for NC/CAPA´s and Customer Complaints
  • Support needed Supplier Audit
  • Perform internal ?Worst Case?-Audit (Role as a ?Worst-Case?-Auditor)
  • Trainings local Management in Audit Topics
Medical Devices
10 Monate
2015-03 - 2015-12

Orthopedic / Trauma / Sports Med Implants and Instruments (Southern Germany and Switzerland)

Senior Quality Engineering & Project Support
Senior Quality Engineering & Project Support
Project Support:
  • Support the local Project Managers and Coordinate a structured Remediation between 3 Sites
  • Support the Change of the complete Product Portfolio (sterile and non-sterile) to UDI (Unique device identification) Compliant Labels
    • Affected products: Sterile Implants, Single-Use, Injectable cements and artificial bone, antibiotic coatings, BMPs
  • Update the internal SOP´s and WI´s to ensure a compliant creation and inspection of UDI-conforming Barcodes and Human readable Information on Labels
  • Point of Contact for all external suppliers and internal worldwide divisions regarding UDI
  • Review ongoing and newly created NCR´s/CAPA´s and Complaints against Labeling / Traceability Issues and implement appropriate Corrections and Remediations
Medical Devices
2 Monate
2015-01 - 2015-02

FDA-Readiness - Final Check (Austria)

Senior Quality Engineering & Project Support
Senior Quality Engineering & Project Support
Project Support:
  • Assess the current status against previous FDA- and Notified Body-Findings
  • Review closed activities before the FDA-Audit is taking place
  • Support the last ongoing Updates of SOP´s / Engineering Documents / Risk Management Files
  • Support finishing the open Complaint Handling activities
  • Preparation the Audit (incl. ?Behavior-Training?)
Medical Devices
1 Jahr 5 Monate
2013-08 - 2014-12

Global FDA Remediation Project

Project 2

Improvement of Processes, Documentation and Sterility Assurance for Implants
and Instruments of the newly created Loaner Department (Switzerland)


Project Support:

  • Support for new Loaner Department:
    • Designing new SOPs
    • Setting up a new Quality System acc. Corporate Standards on-site
    • Quality Agreements against updates needed for the new site
    • Establishing a new Training System for new employees
  • Review legacy documentation for improving the Loaner System
    • Perform Complaint- and CAPA-Reviews
    • Review Scrap- and Review-Rates
  • Support Certification:
    • Preparing for final internal (Corporate-) Audit and ISO Certification
    • Support closure of TÜV-Findings of ?Sister-Sites?
    • Preparation of FDA-Audit


Project 1:

Review of Documentation (DHRs), Archiving System and Sterility Assurance
Remediations for Implants and Instruments against FDA- and TÜV-Findings and
establish appropriate Remediation activities.
(Switzerland, Austria and Germany)


Project Support:

  • Determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.) to Core Team - / Workstream- Leads
  • Audit site related procedures to the standards and report out on findings (both current state and retrospectively) in different sites in Switzerland, Austria and Germany.
    • Provide Audit reports as directed to the local, European and US-Management.
    • Make recommendations to achieve compliance where shortfalls are found.
    • Review and Support of Dose Mappings and Dose Audits and Review documentation of Supplier
    • Review the Validation of Gamma Irradiation - Sterilization
    • Optimize the Pest Control System at 2 Manufacturing Sites
    • Support the Cleaning Validation, Cleanroom Qualification, and ?Water?-Validation
  • Analyzing and Supporting Activities:
    • Perform root cause analysis and corrective / preventive actions for CAPAs as necessary.
    • Perform CAPA verification of effectiveness as necessary.
    • Analyzing NCR- and CAPA files.
    • Analyzing inspection activities.
    • Analyzing maintenance reports and monitoring data.
  • Bringing in of improvement proposals, which increase the productivity and efficiency of manufacturing and facility and operational practices.
    • Consultancy and guidance of all employees regarding maintenance, NCR, CAPA etc.
    • Support Internal Audit
  • Improve the local archiving activities to prevent similar failures in the future
Medical Devices, Switzerland, Germany and U.S.A.
1 Jahr 5 Monate
2013-05 - 2014-09

Quality Engineering & Project Support

Project Support:
  • Support in upgrading the Quality Management (SOPs, Training)
  • Preparation for FDA Submission and Audit
    • focus: Complaints, CAPA, Risk Analysis, Health and Safety Environment, Field Alerts and Actions, etc.)
  • Implementation of a Product Management
  • Implementation of a Supplier Management
  • Support in Technical documents / DMFs for Products: BMPs, vascular grafts
  • Affected products: BMPs, Vascular Grafts, Bone Grafts, Antibiotics, Aseptic productions
R&D company for Pharmaceutical Coatings and Innovative Products, Germany
1 Jahr
2013-01 - 2013-12

Quality Engineering and Interim Management

Project Support:
  • Interim support for the International Product- and Sales Manager
  • Support in the Quality Management (CAPA, Complaints, Risk Analysis, etc.)
  • Training of customers and distributors (worldwide)
  • Initializing and support of studies for international market approvals (FDA, SFDA, CE)
  • Affected products: Hyaluronic Acid, Aseptic production, Injectable
Manufacturer of Hyaluronic Acid, Germany and China
10 Monate
2012-10 - 2013-07

Quality Engineering & Project Support

Project Support:
  • Installation of a complete Quality Management System for Trauma Implants and Instruments (according to ISO 13485) including SOPs, Development procedures, CAPA-System, Complaint Handling, etc. and monitoring of the market approvals,
  • Implementation of a Product Management
  • Training of external suppliers
  • Implementation of a HSE-System
  • Support in the market approval procedures (CE-Mark)
  • Affected products: Sterile Implants
Manufacturer of Medical Devices, Germany and Poland

Aus- und Weiterbildung

Aus- und Weiterbildung

4 Jahre 3 Monate
2005-09 - 2009-11

Studie Health Care Management (?Gesundheitswesen ? Technische Medizinwirtschaft?)

Diploma in Health Care Economics (Dipl. Ges. Oec.), University of Applied Science (Hochschule Niederrhein), Krefeld
Diploma in Health Care Economics (Dipl. Ges. Oec.)
University of Applied Science (Hochschule Niederrhein), Krefeld

  • medical controlling
  • hospital management
  • health economics and reimbursement
  • Diploma thesis: on Request


2 Jahre
1997-10 - 1999-09

Medical School

Medical School, University ? Gesamthochschule Essen
Medical School, University ? Gesamthochschule Essen

1 Jahr 7 Monate
1995-06 - 1996-12

Training for Emergency-Medical-Paramedics

School of Paramedics, Klinikum Niederberg, Velbert/ Fire department, City of Essen
School of Paramedics, Klinikum Niederberg, Velbert/ Fire department, City of Essen

9 Jahre
1986-07 - 1995-06

Higher School Certificate (Abitur)

Higher School Certificate (Abitur), Geschwister-Scholl-Gymnasium, Velbert
Higher School Certificate (Abitur)
Geschwister-Scholl-Gymnasium, Velbert

Position

Position

  • CEO / Senior Consultant / Interim Management (Pharm.& Med. Device / Automotive)
  • QM/ QA/ GMP/ cGMP / GCP / GDP / Regulatory/ Compliance in Medical Devices and Pharmaceutical Companies
  • Project Management
  • Due Diligence- and M&A-Support
  • Integration and Decommissioning- Support
  • Global Remediations
  • FDA Readiness
  • Auditor for ISO & MedDevs / Batch Records and Technical Documentation / EHS-Manager

Kompetenzen

Kompetenzen

Top-Skills

Senior-Berater Auditor Managementberatung Mergers & Aquisitions Due-Diligence-Prüfung Integrationsmanagement Qualitätsmanagement (Einführung...) Prozessmanagement Business Development Managementerfahrung Good Manufacturing Practice Good Distribution Practice Good Documentation Practice Healthcare Risikomanagement FMEA

Produkte / Standards / Erfahrungen / Methoden

METHODICAL EXPERIENCE (EXTRACTS)

1999 - today

Auditing and Training (Automotive, MedDev, Pharma):

  • Internal and External Audit-Support
  • Preparation, Execution and Support with Internal Audits, Supplier Audits, External Audits (for NBs and Customers) and Worst Case Assessments
  • Perform Trainings (incl. Behaviour Training for Employees)
  • Benmarking Audits and Field Visits


2001 - today

Pharmaceutical- and Medical Device Industry specific

Certification Support (Product Related):
  • Support Submission Process
    • Perform Conformity Assessments
    • Create and update relevant files / Tech Docs
  • Communication with Authorities before, during and after Submissions


Communications with relevant Authorities:

  • FDA, BSI, AGES, BfArM, Swiss Med, ANVISA, Notified Body, BGs, AUVA, etc.


Contracts / Agreements:

  • Quality Agreements
    • incl. Design and implementation of APR/APQR
  • URS


Doc. Control:

  • Creation / Implementation, Maintenance and Update of Quality Systems and Documents
  • DHR / Master Records and Batch Reviews
  • GDP Trainings


Due Diligence and M&A-Support

  • Support and perform initial Assessments
  • Full Integration Support
  • Perform Decommissioning Activities


EHS / Health and Safety Management

  • Support as Internal (Interim) or External Safety Manager


GXP-Support

  • GMP, cGMP, GCP, GDP, etc.


Marketing

  • Market Research / New Markets / Business Development
  • Reimbursement (e.g. DRG)
  • Pre- and Post-Assessments and Activities
    • incl. Benchmarking


Post Market Surveillance / Vigilance Systems:

  • Establishment and execution of Field Alerts and Escalation process
  • Creation and Executions of CAPA´s, NCR´s and Deviations
  • Complaint-Handling
  • Support Recalls and Field Actions incl. relevant communications with Authorities (incl. Recall- and Complaint-Handling-Trainings)


Project Management

  • incl. Intervention-Support


Product Management

  • incl. Sales Support
    • User and Customer Trainings


Production / Manufacturing

  • Calibration Activities
  • Labeling, UDI (EU/FDA) and TrackAndTrace (Pharma)
  • Manufacturing Transfer
  • Preventive Maintenance
  • Validation, Verification and Qualification Activities:
    • Plannings and Documentation (Master Plans, Reports, etc.)
    • Qualification/Validation according to ICH-Guidelines
  • Validation / Gamma Irradiation ? Sterilization


Regulatory

  • Internal and communication with Authorities
  • RA-Files Support
    • incl. specific requirements for Narcotics and Oncologics
  • Field Action- and Recall Management


Risk Management

  • Creation and Updates of Risk Files (RMFs, FMEAs, etc.)
  • Risk- and Gap-Assessments
    • RM-Techniques (e.g. 5-Why, FaultTree, Fisbone, etc.)

Standards, Regulations and Guidelines (Extracts)
  • ISO 9001; ISO 10993-1; ISO 13485; ISO 14155-1 and 14155-2; ISO 15225; ISO 15378, ISO 17025; ISO 19011; 21 CFR 820; CMDCAS; ICH Q9, Q10; TR 24971; IEC 62971, EU Phr., ISO 4806-1/-2 
  • 2017/745 (EU MDR) ; 93/42/EEC (MDD); 90/385/EEC (AIMD); 2017/746 (EU IVDR); 98/79/EC (IVDD) 
  • EU Phr., USP

PROFESSIONAL EXPERIENCE

2013 - today
Role: Founder Member of DIN EN 15224-Competence-Network

2011 - today
Role: Certified EHS Manager (?SIFA? or ?FASI?)
Customer:  Verwaltungs-Berufsgenossenschaft, Germany (2011) and WiFi, Austria (2020)

10/2008 - today
Role: CEO (and Founder) 
Customer: on Request

Tasks:
  • Development, Implementation and Upgrade of Management-Systems (e.g. Quality, Risk, HSE, Environment)
  • Trainings and Courses (e.g. Emergency-Trainings)
  • Services / support in
  • Optimization of health and safety / Emergency-Management
  • Optimization of working processes
  • Product- and Interim management
  • Approval of Medical Devices
  • Attending of Clinical Studies
  • External Auditor (for different certifying companies and Notified Bodies)
  • External Health and Safety Manager
  • Expert for Medical Devices (for different Notified Bodies)

2011 - 2015
Role: External Expert for Quality Management and Medical Devices
Customer: mdc ? medical device certification GmbH, Stuttgart

2010 - 2015
Role: External Expert / Auditor (ISO 9001, 13485 and MDD active/non active, technical documentation)
Customer: TUEV Nord Cert GmbH, Essen

07/2006 ? 09/2008

Role: Product Manager Spine und Biomaterials
Customer: Clinical House GmbH, Bochum / Synthes, Oberdorf (Switzerland)

Tasks:
  • Responsible PM for Cervical Spine und all Biomaterials
  • Quality manager for the existing DIN EN ISO 9001 und 13485 certifications
  • Support and Evaluation of clinical studies for the approval of new products
  • Closure of the company at 30.09.2008

07/2003 ? 06/2006
Role: Territorial Manager for Northern Germany (Niedersachsen, Bremen, Schleswig-Holstein, Hamburg and Mecklenburg-Vorpommern)
Customer: ZOLL Medical Deutschland, Cologne

Tasks:
  • Responsible for all products (defibrillators, resuscitation products, Volume-Therapy (Military) und Quality management
  • Support and Evaluation of clinical studies for the approval of new products and the upgrade of existing products (In German hospitals, ground- and air-based Emergency Medical Services) in co-operation with the U.S. headquarter

07/2001 ? 06/2003
Role: Paramedic and Trainer
Customer: Johanniter-Unfall-Hilfe (St. Johns), Ortsverband Stedingen / Weser-Ems

Tasks:
  • Responsible for the Emergency Medical Service und Training of the personnel
  • Co-operation with Medical Device Companies (testing new products and market evaluations, etc.)

01/2001 ? 06/2001

Role: aramedic (Air and Ground) and Trainer

Customer: Berufsfachschule für den Rettungsdienst , incentiveMED, Erbach (Odw.)

04/1996 ? 12/2000
Role: Paramedic and Trainer

Customer: Berufsfeuerwehr and Malteser, Essen


TECHNICAL EXPERIENCE EDV-SOFTWARE

  • Software- / ERP- / Doc. Control- Systems
    • SAP
    • VFlow
    • Filemaker
    • AGILE
    • EtQ
    • TrackWise
    • VEEVA Quality Suite
  • Conference Tools:
    • TEAMS, WebEx, ZOOM, FaceTime, CISCO, etc.
  • Windows and MS-Office Tools:
    • Word, Excel, PowerPoint, MS-Visio, MSProjects, Office 365 1995 Advanced
  • Apple OS and Tools:
    • iWorks (Apple own ?Office? solution)
    • IOS, iPadOS, WatchOS and MacOS

Branchen

Branchen

  • Automotive (2009)
  • Pharmaceutical Industry (2006)
  • Medical Devices Industry (2003)
  • Emergency Medical Service / Hospital (1995)

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