Validation Specialist, GMP Biopharmaceuticals | Pharmacist (m/w/d)
Coriolis Pharma Research GmbH
Job Summary
This specialist role within the Quality Control Team of a global CRDO focuses on ensuring compliance and excellence across qualification and validation activities for liquid and lyophilized drug products. The successful candidate will compile, review, and approve documentation for instrument qualification and analytical method validation, ensuring adherence to GMP regulations and internal procedures. Key responsibilities include defining validation strategies, managing the validation lifecycle, conducting risk assessments, and acting as a critical interface between the GMP operative team, QA, and IT. Applicants must hold a Master’s degree (PhD preferred) in Pharmacy, Chemistry, Biology, or a related natural science field, coupled with documented training in GMP and a minimum of three years of professional experience in a regulated biopharmaceutical environment. This position offers a chance to contribute to innovative drug development within a science-driven, diverse, and quality-focused international organization near Munich.
Required Skills
Education
Master’s degree or equivalent in Biology, Chemistry, Pharmacy, or another field of natural science; PhD preferred. Documented training in GMP regulations, Quality Management Systems, equipment qualification, and method validation.
Experience
- Minimum 3 years of professional experience in equipment qualification and method validation
- Professional experience within a regulated biopharmaceutical environment
- Hands-on experience compiling and reviewing qualification and validation protocols and reports
- Experience supporting internal and external audits and inspections
Languages
Additional
- Not specified
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