6 months ago
Qualified Person/ Junior Qualified Person role!
Our Client in Schorndorf is the flagship EU manufacturing location for large scale reliable supply of complex controlled release oral solid dose forms through state-of-the-art fluid bed granulation and hot melt extrusion capabilities, integrated development, commercial manufacture, and packaging.
- Pharmacist with approbation as a pharmacist or comparable
- Suitability for designation as a Qualified Person according to AMG §15 (1) and (4)
- Ideally, experience with clinical investigational medicinal products
- Several years of professional experience in the GMP-regulated environment
- Work experience in quality assurance as well as audit experience desired
- Assertive personality; Flexibility and resilience; team Player
- Fluent German and English spoken and written
- Certification of drug batches as a knowledgeable person
- Participation in the development, production, testing, and approval of medicinal products as a qualified person in accordance with §§ 13, 15 AMG
- Information and advice to employees, physicians, and other healthcare stakeholders through a product risk assessment of drugs
- Keeping a continuous register of all released batches in accordance with § 19 AMG in conjunction with § 17 AMWHV
- Final evaluation and approval of deviations and complaints
- Auditing of manufacturing and testing facilities
- Ensuring the proper retention of restitution patterns
- Participation in the supervision of customer audits and official inspections
Interested? Click on the apply button below!