Qualified Person (Sachkundige Person) (AG284505) Munich, Germany
Sustainably growing, this Swiss generics company is expanding its commercial operations all over the world. For that reason, they are strengthening their Quality Assurance department in their Munich location and hiring a new Qualified Person (Sachkundige Person). In this role, the Qualified Person (Sachkundige Person) will help a great pharmaceuticals company bring great value for a lot of people worldwide by contributing to the commercialization of good quality medicinal products.
As a Qualified Person (Sachkundige Person), your main tasks will be:
-Participate in the manufacturing and testing of externally produced medicinal products according to the AMG (German drug law) §14
-Certificate drug batches according to EU GMP guidelines
-Coordinate, organize and execute audits
-Process, review and approve deviations, CAPAs, complaints, and change requests
-Take an active part in the creation and review of SOPs and GMP documents
-Coordinate product launches from a Quality Assurance perspective
Your profile is:
-A university degree in Pharmacy
-Qualification as a Qualified Person according to §15 AMG
-At least three years of professional experience in the industrial manufacture and testing of pharmaceutical products, this is, quality control, quality assurance, production, and development
-Knowledge of SAP
-Good knowledge of drug laws and up-to-date national and international GMP regulations
-Fluent in English
If you are a team-oriented, confident, and responsible QP with vast experience in quality in the pharmaceutical industry, this job is for you! Apply below or send your CV to a.garayalde@nonstop-recruitment.com or share it with all your friends!