Quality Investigations Lead (Sterile Products)
📍 8442 Hettlingen CH
Role and responsibilities
Lead and coordinate deviation and complaint investigations in a sterile GMP environment Identify root causes and drive effective, sustainable CAPAs Ensure timely, compliant documentation of all investigations Collaborate cross-functionally with QA, Manufacturing, and Regulatory Affairs Monitor trends and improve investigation processes and quality standards
Team / 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.
Qualifications and Skills
Degree in Life Sciences, Pharmacy, Chemistry, or a related field
5+ years’ experience in quality investigations within sterile GMP manufacturing
Strong knowledge of GMP and FDA requirements for sterile products
Proven expertise in root cause analysis and CAPA management
Fluent in English and German