Our client is a professional Biotechnology and Pharmaceutical organization, based in Baden-Württemberg Germany.
Our client is a global Pharma company in Germany.
Our client is looking for a QA specialist with Pharma and Medical Device experience dealing with combination products.
- Compliance and implementation of regulations for devices and biologics - Maintain and improve QA Risk Management procedures - Work together with R&D, Operations, Sales and Marketing and other departments - Coordinate design changes and design control of combination products - Ensure QA regulatory compliance
- B.Sc. / Bachelor in Chemistry, Pharmacy, Biology, Microbiology, Engineering or related - 5+ years experience with QA QMS - Leading team experience - Knowledge of ICH, ISO, US Code, FDA and EU regulations - Experience in dealing with regulatory authorities - Excellent English skills
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