Manager QA Operations & FvP (m/w) 100%
Ophtapharm AG · Zürich, Zurich, CH
Ophtapharm AG is an FDA/EU-GMP certified manufacturer in the pharmaceutical sector (ophthalmic products). At our production site in Hettlingen near Winterthu...
Job description
Ophtapharm AG is an FDA/EU-GMP certified manufacturer in the pharmaceutical sector (ophthalmic products). At our production site in Hettlingen near Winterthur, high-quality products such as eye drops, ointments, and gels are aseptically produced, filled, and packaged for international markets. Manager QA Operations & FvP (m/w) 100% To support our team in Hettlingen, we are looking for a Manager QA Operations & FvP to join us as soon as possible. Ihre Aufgaben: - Act as the Responsible Person (FvP) acc. to Swiss Drug Law• Manage and further develop the QA Operations Team• Ensure batch disposition on time• Manage key elements of a QA Operations including non conformities, complaints, CAPA, change control, risk management, PQR/APR, training• Monitor Quality Metrics (Key Performance Indicators) accordingly• Lead inspection readiness activities, represent your department in inspections and customer audits• Lead the compendial compliance process• Lead continuous improvement in the area of your responsibility• Stay updated on industry trends, regulations and evolution of Health Authority expectations• Deputize Director Quality Ihr Profil: - PhD or MSc in Pharmacy, Biology, Microbiology or...