a Randstad company

Quality Management in Pharma&MedTech / GMP / Quality / Digitization / Qualified Person (Austria) / Project & Interim Management

Profil
Top-Skills
GMP Quality Management Interim Management Computer-Aided Quality Management Quality Control Quality Assurance Qualified Person Project Management PMP Quality Engineering Processautomation Process Management Lean Six Sigma Continuous Improvement CAPA Management Audit Management Change Control Digital Transformation Consulting
Verfügbar ab
09.01.2023
Bald verfügbar - Für planbare Projekte: Der Experte steht für neue Folgeprojekte zur Verfügung.
Verfügbar zu
100%
davon vor Ort
15%
Einsatzorte

Städte
München (+300km)
PLZ-Gebiete
Remote-Arbeit
möglich
Art des Profiles
Freiberufler / Selbstständiger
Der Experte ist als Einzelperson freiberuflich oder selbstständig tätig.

11 Monate

2022-02

2022-12

QMS Re-Engineering and Implementation of eQMS

Project Manager, Quality Manager, Validation Lead GMP Projektmanagement Pharma
Rolle
Project Manager, Quality Manager, Validation Lead
Projektinhalte

Market release of nutraceuticals and API's (CoA-based).

Re-engineering of legacy QMS (SOP and policy creation).

Project Manager for roll-out of electronic Quality Management (System MasterControl) - Document Management and Training Management Modules. 

MasterControl SysAdmin after system Go-Live.

Kenntnisse
GMP Projektmanagement Pharma
Einsatzort
Remote
4 Monate

2021-09

2021-12

Leading a Quality Unit (Head of Quality) - Pharma CMO

Head of Quality
Rolle
Head of Quality
Projektinhalte
  • Responsible for Site Quality Unit (50+ FTE in QA & QC)
  • Ad-interim role of Head of QA (vacant)
  • Ongoing Site Remediation Project Management
  • Ongoing Quality Agreement Remediation Project support
  • Initiation and hands-on management of Overdue CAPA Remediation Project; Reduction of count by approx. 20% achieved in one month, mid-term strategy launched
  • Budgeting for Quality Unit
  • Lean QC efficiency project start-up
  • Establishment of production planning-based workload forecast for demand-based management of future QC workload and for reduction of current QC analytical backlog
  • Staffing of vacant QA department roles and transition planning for key roles due to ongoing QA reorganization
  • Quality KPI reporting for local and global organization
  • Conduct of Quality Board and follow-up on action items
  • Assessment of key compliance gaps and development of strategy for sustainable uplift of GMP level with the long-term goal to install a modern, efficient QMS and reach inspectionreadiness
Kunde
on request
Einsatzort
Germany
2 Jahre 8 Monate

2019-01

2021-08

Digital Consulting in Life Sciences

Principal
Rolle
Principal
Projektinhalte

2021-04 - 2021-07

  • Project Manager for biopharmaceutical manufacturing IT/OT assessment project, Global Biopharma client 


2021-02 - 2021-04

  • Subject Matter Expert for pharmaceutical manufacturing in Project ?Digital Performance Boards? ? Design and digital roadmap for a Continuous Manufacturing Digital Dashboard; Global Pharma client 


2019-10 -2019-12

  • Consulting services: Establishment of a Global MES System Technical Change Management process & SOP; Global Biopharma Client 


2020-07 - 2020-07

  • Subject Matter Expert for pharmaceutical quality business processes (QA, QC, QMS) in internal Project ?Digital Greenfield Reference Plant? 


2020-06 - 2020-06

  • Sub-Project Manager for workstreams Design Transfer, Design Changes, Service Tools in a complex, international MedTech R&D Project; Global MedTech Client


2019-02 - 2019-04

  • Consulting services: Ad-interim Project Governance for a Global MES Implementation Project in a pharma manufacturing plant in China (remote); Global Biopharma Client
  • Business development, sales support and solution selling

Kunde
on request
Einsatzort
Germany
2 Jahre 5 Monate

2016-08

2018-12

Quality Consulting Services for Life Sciences

Senior Consultant
Rolle
Senior Consultant
Projektinhalte
2018-09 - 2018-12

  • Consulting services: Senior Quality Systems Engineer ? Overdue CAPA & Audit Observation Remediation for Global MedTech Client


2016-09 - 2018-09

  • Quality Systems Engineer for DePuy Synthes, Plant Salzburg, Austria, labor leasing contract, details above


2016-08 - 2019-09

  • Consulting service for Utilities Qualification Project; Global  Biopharma Client

  • Sales support in business closing and solution selling
  • German coordinator for Altran-internal international knowledge sharing transfer program (PULSE)
  • SPOC for Biopharmaceutical Industry client (interviewing, staffing and placement of consultants)

Kunde
Altran S.A.S. & Co. KG, Munich, Germany
2 Jahre

2016-09

2018-08

Quality Operations Management

Quality System Engineer
Rolle
Quality System Engineer
Projektinhalte
  • Responsible for local QMS system implementation, maintenance, and continuous improvement; coordination of Quality Team Inspection and Test (4 FTE); audit readiness and audit observation / CAPA coordination; investigation and escalation of quality issues
Kunde
DePuy Synthes Österreich GmbH, Salzburg, Austria
4 Jahre 4 Monate

2012-04

2016-07

Lean Transformation & MES EBR Implementation Project Management

Project Manager Operational Excellence
Rolle
Project Manager Operational Excellence
Projektinhalte
2013-01 - 2016-07

  • Project Manager for MES EBR Rollout Project: Deployment of WERUM PAS-X MES system for approx. 900 TechOps end users: leading a cross-functional project team of 2-10 FTE; managing 2,4 Mio? budget; implementing required hardware, software changes, end-user training & buy-in for electronic batch recording (paper-on-glass approach) in pharma manufacturing


2012-04 - 2013-01

  • Project Manager for TechOps Lean Transformation Project in Sterile FDF Production as follow-up of a McKinsey study: Leading a cross-functional project team of approx
  • 5 FTE for evaluation and implementation of various LEAN tools, methods and processes on the shopfloor, employee mindset change and buy-in for LEAN principles
  • Lean Six Sigma Program initiation and deployment in TechOps
  • Employee suggestion system coordinator for TechOps

Kunde
TechOps, Sandoz GmbH, Kundl, Austria
1 Jahr 5 Monate

2010-11

2012-03

CI Program & Project Management

Head Global Process Management
Rolle
Head Global Process Management
Projektinhalte
  • Providing technical support, monitoring performance, and driving continuous improvement initiatives and projects for Sandoz Global Manufacturing Network Anti-Infectives (7 European sites, 1 Asian site)
  • Change Agent for Global Lean Six Sigma Program deployment in Sandoz Business Unit Anti-Infectives 
  • Project Manager for ?Theoretical Limit in Energy Management? pilot project at Sandoz Site Frankfurt 01-03/2012: hands-on feasibility study of McKinsey methodology, identification, and evaluation of yet unknown levers for energy savings (approx. 500 k? p.a. potential identified with payback < 2 years)
Kunde
Business Unit Anti- Infectives, Sandoz GmbH, Kundl, Austria
2 Jahre 9 Monate

2008-02

2010-10

QC Lab Head; Process improvement & troubleshooting

Head IPC Analytical & Technical Process Support Labs
Rolle
Head IPC Analytical & Technical Process Support Labs
Projektinhalte
  • Management of 12 lab associates in a QC laboratory
  • Technical process improvement & troubleshooting of API manufacturing processes
  • Analytics, QC, IPC of raw materials, intermediates, API's and FDF's; analytical methods including e.g. pharmaceutical water analysis, HPLC, GC, GPC, UV/VIS, enzymatic methods, physical characteristics, electrophoresis, Karl-Fischer
Kunde
Sandoz GmbH, Schaftenau, Austria
5 Jahre 1 Monat

2003-01

2008-01

QC Lab Head

Head IPC Analytical Laboratory
Rolle
Head IPC Analytical Laboratory
Projektinhalte
  • Management of 8 lab associates in a QC laboratory
  • Uplift of GMP level to ongoing inspection readiness
  • Analytics, QC, IPC of raw materials, intermediates, API's; analytical methods including e.g. pharmaceutical water analysis, HPLC, GC, UV/VIS, enzymatic methods, physical characteristics, Karl-Fischer
  • Information security coordinator; SAP business super user
Kunde
Sandoz GmbH, Schaftenau, Austria

4 Monate

2018-09

2018-12

Post gradual studies in ?Pharmaceutical Quality Management?

Certified Qualified Person § 9 AMBO 2009 by AGES, University of Vienna, Austria
Abschluss
Certified Qualified Person § 9 AMBO 2009 by AGES
Institution, Ort
University of Vienna, Austria
6 Jahre 10 Monate

2006-04

2013-01

Business Administration and Economics

Diplom-Wirtschaftschemiker; Grade: 2,5, Distance University of Hagen, Germany
Abschluss
Diplom-Wirtschaftschemiker; Grade: 2,5
Institution, Ort
Distance University of Hagen, Germany
3 Jahre 11 Monate

1999-01

2002-11

Ph.D. in Analytical Chemistry

Dr. rer. nat.; Grade: 1,0 (magna cum laude), Institute of Organic Chemistry, University of Tübingen, Germany
Abschluss
Dr. rer. nat.; Grade: 1,0 (magna cum laude)
Institution, Ort
Institute of Organic Chemistry, University of Tübingen, Germany
2 Jahre 6 Monate

1999-04

2001-09

Graduate Program "Analytical Chemistry"

Schwerpunkt
  • Quantitative analysis and characterization of pharmaceutically and biochemically relevant substances
6 Jahre 4 Monate

1992-10

1999-01

Study of Chemistry

Diplom-Chemiker?; Grade: 1,2, University of Tübingen, Germany
Abschluss
Diplom-Chemiker?; Grade: 1,2
Institution, Ort
University of Tübingen, Germany
1 Jahr 1 Monat

1995-08

1996-08

Graduate Exchange Student

University of Massachusetts at Amherst, MA, US
Institution, Ort
University of Massachusetts at Amherst, MA, US
1 Jahr

1991-07

1992-06

Military Service

Landsberg/Lech and Engstingen, Germany
Institution, Ort
Landsberg/Lech and Engstingen, Germany

1978 - 1991

Burladingen and Hechingen, Germany; ?Abitur? Grade: 2,0


Certifications
  • PMP (by PMI); LSSBB (by CSSCC); QP (Austria) / § 7 AMBO 2009 (by AGES); CMQ/OE, CQA & CPGP (by ASQ)
  • Diploma Applied Data Management (?Good?) by e-Learning Group
  • Qualified Person for Austria (§ 7 AMBO) 2009 by AGES
  • Certified Manager of Quality/Organizational Excellence CMQ/OE by ASQ
  • Certified Quality Auditor CQA by ASQ
  • Certified Pharmaceutical GMP Professional CPGP by ASQ


Selected Professional Trainings

2021 - 2021

  • Diploma course ?Angewandtes Datenmanagement?, E-Learning Group
  • MES PAS-X Technical Training, Accenture


2020 - 2020

  • Design Thinking Academy, Accenture
  • Leading Change, Reet-Beratung
  • Data Driven Consulting Program 201, Northwestern University


2019 - 2019

  • Technologie, Strategie und Leadership, MOOC.house
  • Data Driven Consulting Program 101, Northwestern University
  • Data Integrity & Part 11 Risk Management, ISPE
  • Consulting University for Managers, Accenture


2018 - 2018

Pharmaceutical Quality Management, Uni Wien


2017 - 2017

  • Big Data Analytics, MOOC, openHPI
  • Process Mining: Data science in action, MOOC by coursera.org
  • Mastering Digital Transformation, MOOC, openHPI


2016 -2016

Hands-on Industrie 4.0, MOOC, openHPI


2015 - 2015

  • Technology and Innovation Management, FernUni Hagen
  • Impact in complex environments, JP-Consulting & Training


2014 - 2014

  • Lean Six Sigma Black Belt Training, Novartis/Valeocon
  • Lean Assistant, Lean Management Institute
  • ICE IT Project Management Silver, Sandoz


2013 - 2013

MS Project, Abadir


2012 - 2012

Project Management, FernUni Hagen


2011 - 2011

  • Improvement systems and programs; Qualitätsfachkraft, TQU
  • Financial Fundamentals Program, Novartis
  • Leading for results, Novartis
  • Making use of negotiation situations, WilfertundBahr


2010 -2010

  • 1x1 of Fermentation, Haus der Technik Essen
  • Lean Six Sigma Green Belt Training, Novartis/Valeocon


2009 - 2009

Project Management, EGOS!


2008 - 2008

  • Process Optimization using Design of Experiments, Novartis
  • Scale-up for Tech. Chemists and Biotechnologists, Dechema


2007 - 2007

Virus- and TSE-Safety, Concept Heidelberg


2006 - 2006

  • Pharma water: FDA- und GMP-compliant, Concept Heidelberg
  • Leading Teams, Novartis


2005 - 2005

Economic basics; EGOS!


2004 - 2004

  • Statistical evaluation of measurement data, Novartis
  • Leading at the Frontline, Novartis


2003 - 2003

  • Occupational safety management, Du Pont Academy
  • Training for presenters in GMP audits, PCI

Quality Management; Interim Management; Consulting

German mother tongue
English fluent
French high school skills
Spanish basic skills

Top Skills
GMP Quality Management Interim Management Computer-Aided Quality Management Quality Control Quality Assurance Qualified Person Project Management PMP Quality Engineering Processautomation Process Management Lean Six Sigma Continuous Improvement CAPA Management Audit Management Change Control Digital Transformation Consulting
Produkte / Standards / Erfahrungen / Methoden
Personal Profile

  • Competence: +18 years? experience in GMP & Quality (QC, QA, QMS), Operational Excellence, Project Management and Digital Transformation in the Pharmaceutical and Medical Devices Manufacturing Industry


Career Objective

  • Provide advice and leadership for Quality Management in the Life Science Industry in the age of digital disruption


Skills

MS Office: 

  • Word
  • PowerPoint
  • Excel


Project Management SW:

  • MS Project
  • Jira


PLM / Technical Change Control SW:

  • Polarion


Business Process SW:

  • WERUM PAS-X (MES EBR)
  • SAP R/3


Statistical / DoE / Analytics SW:

  • Minitab
  • Statgraphics
  • Stavex


Laboratory SW:

  • LIMS


Quality Management Systems SW:

  • EtQ
  • TrackWise


Document Management SW:

  • Agile
  • Windchill
  • DHC

Qualitätssicherung
Quality Assurance
Experte
Quality Control
Experte
Quality Systems Engineer
Experte
Quality Management
Experte
Labor / Qualitätskontrolle
Head of QC
Experte
Head of Inspection and Testing (Med.Devices)
Fortgeschritten
Produktion & Fertigung
API Manufacturing
Fortgeschritten
Medical Device Manufacturing
Basics
Managementerfahrung in Unternehmen
Head of QC; Head of Quality; Head of Process Management; Project Management
Experte

Active Pharmaceutical Ingredients (API); Pharmaceuticals (Bulk, FDF, Packaging); Medical Devices (Class IIb, III) Industry


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