Compliance Officer (Pharmaceutical Environment) | Compliance Officer (m/w/d) im pharmazeutischen Umfeld
FERCHAU GmbH Wiesbaden Pharma & Life Science
Job Summary
This critical role seeks a dedicated Compliance Officer to serve as the primary contact and decision-maker for all pharmaceutical and Good Manufacturing Practice (GMP) related issues within manufacturing operations. You will actively support the Head of Production, ensuring the highest standards of quality and regulatory compliance are maintained across all production sites. Key responsibilities include the thorough processing, evaluation, and documentation of deviations, complaints, and technical or pharmaceutical changes. Furthermore, the officer will be responsible for creating, reviewing, and approving Master Batch Records, manufacturing reports, and comprehensive batch documentation. The position also involves leading GMP training sessions, developing internal guidelines, and rigorously preparing for and participating in internal and external audits, including managing necessary follow-up actions. Success in this role requires a background in Pharmacy or a related field, strong regulatory knowledge (EU-GMP, 21 CFR 210/211, AMWHV), and an analytical, solution-oriented approach.
Required Skills
Education
Degree in Pharmacy and Pharmacist License (Approbation) OR related degree with equivalent professional experience
Experience
- Several years of professional experience in the pharmaceutical industry
- Professional experience supporting the Head of Production functions
- Experience in documenting and evaluating deviations and complaints
- Experience in preparing and conducting GMP training
Languages
Additional
- Not specified
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