Qc Microbiology Manager
7 days ago
Walker Cole International is currently searching for a QC Microbiology Manager to join a leading Cell and Gene Therapy company based in London.
As a QC Microbiology Manager, you will be responsible for:
- Drafts and leads the implementation of the Microbial Contamination Control Strategy documentation
- Supporting the preparation and follow-up of internal/external audits and Regulatory inspections; acts as an expert during audits / inspections presenting aspects related to the microbial control strategies and associated mitigations and improvements.
- Leading and approving quality risk analysis (e.g. FMEA), reviews related change Requests, deviation/investigations, CAPAs as a SME for Microbiology issues
- Participate and provide SME inputs for ongoing development and delivery of gowning and aseptic awareness training for all GMP manufacturing staff.
- Leading cross-functional/site reviews and update local documents in accordance with Microbial contamination control program/strategy.
- Leading in complex deviation investigations, contamination and microbiological investigations, change controls, CAPA proposals and closure of non-conformance reports.
A successful QC Microbiology Manager will have:
- MSc or BSc with primary degree in Microbiology Sciences or similar
- Experience or knowledge of Environmental Monitoring methods and in process controls commonly used in manufacturing processes techniques.
- Client oriented. Establishes effective and responsive relationships with all clients; able to translate client projects into a feasible process design; known to ensure value is always delivered to the client
- Knowledge of electronic notebooks (e.g. Benchling, or LIMs)
GMP I Quality Control I QC I Microbiology I Environmental Monitoring I CAPA
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