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QC Microbiology Manager

WALKER COLE INTERNATIONAL LTD
Job LocationLondon
EducationNot Mentioned
Salary55,000 - 65,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

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 and ability to apply GMP legislation in conformance with FDA, MHRA, EU and ICH standards
  • Knowledge of electronic notebooks (e.g. Benchling, or LIMs)
GMP I Quality Control I QC I Microbiology I Environmental Monitoring I CAPA

Keyskills :
Environmental MonitoringGMPMicrobiologyQuality Control

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