QC Validation Manager - 1 Year FTC
London, United Kingdom
MeiraGTx
The QC Validation manager is responsible for the validation and transfer of novel and established test methods for the analysis of gene therapy products and associated materials used for manufacturing the EU and FDA GMP requirements at both the Meiragtx UK and Ireland sites. The role involves life cycle management of assays, equipment and materials/products. Job Description … own area of responsibility, is closed timely and in a RFT state. Key JobCompetencies • Implement/qualify/validate analytical methods for the GMP testing of products and aseptic manufacturing facilities - understanding of regulatory requirements for analytics and stability for ATMPs. • Problem Solving - Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully; develops alternative solutions … parallel and working in a flexible way. • Proficiency in a body of information required for the job e.g knowledge of EU and FDA regulations, GMP/GLC/GCP, Lean Manufacturing, Six-Sigma, etc. • Proficiency in IT, Microsoft Office software (Word, Excel, Powerpoint) preferred. • Must be willing to travel between the two Meiragtx sites. Why us More ❯
Employment Type: Permanent
Salary: GBP Annual
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