Close collaboration with the Quality team to align on concept and proper application of existing quality systems and support their development * Solid quality background, specifically with core GxP systems like Change Control, Deviation Management, CAPA * Professional experience in quality or regulatory in manufacturing pharma industry, CMO/CDO/CDMO companies or in industry developing, manufacturing, and marketing of equipment for use in pharmaceutical manufacturing * Professional experience with specific quality tools used in pharmaceutical industry like: Computer software validation (CSV) based on the principles of e.g. 21CFR11, Equipment qualification (IQ/OQ) Eurdalex Vol 4 Annex 15, Process Validation, Extractable / Leachable data generation and evaluation, Critical impurities and contact material compliance (e.g. TSE)
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