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nidia.gil@gxp.ch oder +41 79 470 48 24
Education and Training
- B. Sc. Biochemie
- Certified Project Manager
- Continuing education GMP, Quality Management Systems, aseptic production
Professional Experience
- Deputy Qualified Person (fvP under Swiss Law)
- Development of Quality Management Systems
- Audit Management of customers and authorities (Swissmedic, FDA, ISO 9001 and 13485)
- Leading Inspection Readiness
- Deviation, Investigation, CAPA and Change Control Management
- Supplier and material management, Qualification
- Implementation of new guidelines (e.g. Annex 1, GMP-Leitlinien, USP and Ph. Eur., Nitrosamine, elemental impurities, visuell inspection of ophtalmic)
- Risk analysis and risk management processes
- Raw material and productspecific risk analysis
- Continuing improvement of processes
Languages
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