GMP-Consulting

Mehr als 20j Erfahrung

• Auditor
• Change Management
• Data Integrity Expert Level 4
• DIN EN ISO 13485
• Gute Herstellungspraxis (GMP)
• Messmethoden (allg.)
• Prozessvalidierung
• Qualitätsmanagement / QS / QA (IT)
• Risk Management and Sustainability
• Supply-Chain-Management (SCM)

Profile
Education
- 1995 M. Sc. Physics at the University of Hannover
- 1998 M. Sc. Biomedical Engineering at the Medical University of Hannover
- 2002 Dr. rer. Nat. At the Medical University of Luebeck in the Institute of Biomedical Engineering,

Expertise
- Over 20 years of experience as GMP Consultant in the pharmaceutical, dental, and medical device industry
- Certified data integrity expert – Green Mountain quality assurance

Qualifications
- Experience knowledge and qualification in computer system validation (CSV)
- Experience Knowledge and qualification in Management in the Life Science Industry (9 years as COO)
- Experience Knowledge and qualification in Project Management in the Life Science Industry
- Experience knowledge and qualification in GLP, GMP- / FDA requirements, 21 CFR 210, 211, 58, 820 and 11, EN ISO 13485, ISO17025
- Experience knowledge and qualification in Data Integrity
- Experience Knowledge and qualification in aseptic manufacturing and sterilization
- Experience Knowledge, and qualification in system qualification and process validation
- Experience Knowledge and Qualification in cleaning and cleanroom validation
- Experience Knowledge in Cleanroom manufacturing and Environmental Monitoring
- Moderation and implementation of risk assessment FMEAs
- Experience and knowledge in handling of CAPAs, production deviations, and audit findings

Selected projects
- Computer system validation (ERP systems, production DAQ systems, laboratory LIMS systems, production control systems)
- Implementing eQMS including but not limited to CAPA, deviation, and complaint procedures for GMP Organizations
- GMP training (GMP, R&D, CAPA management, change management, complaint management, CSV, DI, process validation, risk management)
- Consulting R&D projects with hands-on on in pharmaceutical, medical device, and dental
- Audit management support (pre-and post-audit) for GMP-audits
- Process validation and optimization of validated processes
- Implementing of cleaning validation strategy for Implants
- Implementing cleaning validation for API production
- Implementing qualification and validation strategy in manufacturing and Laboratory
- Process validation and optimization of validated processes
- Performance of GMP audits, Analyses, and supplier qualifications in Germany, France, Switzerland, Austria, and Great Britain
- Metrology and methods validation
- Implementation and validation of water system (AP and WFI)
- Auditing of validated processes


Selected companies I worked with as a freelancer GMP-specialist since October 2003: CeramTec AG in Plochingen, Stryker Trauma in Kiel, Finetubes in Plymouth (GB), Mathys AG (CH), Pari Medical in München, DOT in Rostock, LPT in Hamburg, Medtronic in Degendorf, StrykerLeibinger in Freiburg, Hegedüs in Mühlheim-Stetten, Prototyp Werke in Zell Am Harmersbach, Thermo Scientific in Bremen und Karlsruhe, Fatol GmbH in Schiffsweiler, Riemser Arzneimittel in Gengenbach und Helixor GmbH in Rosenfeld, Zimmer (CH/F), PaL (D/GB), Boehringer Ingelheim (D), Merck (D), chemische Fabrik Budenheim (D), Osartis (D), Getinge (D).

Forschung & Wissenschaft
- Physik

Technik & Ingenieursberufe
- Medizintechnik

Medizintechnik