Close to 30 Years’ experience in the daily business of sterile/ aseptic production (for bulk pharmaceuticals/ final dosage forms and biopharmaceuticals) and QA/ QC Microbiology
Worked as an independent consultant with different clients and contractors worldwide (50 assignments in Europe, USA, India, Brazil and Korea)
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Our content and services may vary by location.
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Overview
- Availability
- Asap, 5 days/week, on-site & remote
- Qualification
- Master of Science in Microbiology
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Hygiene Concepts, Aseptic Processing and Sterile Production Microbiological Analysis, Sluices, Clean Room, Risk Analysis, Change Control, CAPA, Deviation Management, Quality Management Systems, GMP, Pharma, Biotechnology
Key-Facts
Extract from previous activities
Biopharmaceutical Company, Germany
Sterility Assurance Expert
Sterility Assurance Assessment at two as “critical” rated sterile production sites
FDA audit preparation & audit at a sterile API plant Training at the Shopfloor
Provided microbiological support for new sterile prefilled-syringe production: Definition of requirements for sterile manufacturing rooms, development of the personnel and material smuggling processes, development of the gowning concept
Biopharmaceutical Company, Germany
Expert Aseptic Production
Batch Record Review
Change Control Systems and Deviation Investigation Review
Plant Walk Through
Shopfloor- und Aseptic Operations Training
Upgrade EM Program
Biopharmaceutical Company, Spain
Expert Aseptic Processing & Monitoring Systems
Supervised and optimized cleanroom monitoring (Class A, C, & D) and water/gas systems; developed monitoring and gowning concepts
Qualification of the personnel and material smuggling processes
Verification of the effectiveness of cleaning and disinfection measures of the rooms
Pharmaceutical Company, USA
Contamination Expert
Material/waste transfer concept Validation of decontamination procedures Environmental monitoring
Developed a microbiological process for degrading organic components in galvanic rinsing waters
Follow up on CAPAs
Biopharmaceutical Company, Germany
FDA Mock Audit – Hygiene & Sterile Production Expert
Sterile Production/ Aseptic Processing/ Sterilization/ Cleaning & Disinfection/ Environmental Monitoring
CAPA Verifications
Verification of the effectiveness of cleaning and disinfection measures of the rooms
Disinfectant testing Material/waste transfer concept
Shop Floor Training and Mentoring, e.g. practical Training of clean room operators
Workshops about hot topics