Senior Quality Investigator – Sterile Manufacturing & Microbiology

Lead major and critical investigations related to sterility, contamination, environmental monitoring and aseptic operations. Define investigation strategies, containment measures and sampling plans together with SMEs and the FvP. Identify root causes and drive effective CAPAs based on microbiological, process and manufacturing data. Review and approve investigations, ensuring scientific rigor and regulatory compliance. Support audits and inspections and coach investigators on complex cases.

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. Quality Investigations team plays a key role in ensuring product quality and compliance in a sterile GMP environment. Working closely with QA, Manufacturing and Regulatory Affairs, the team drives investigations, identifies root causes and supports sustainable quality improvements.

• Degree in Microbiology, Biology, Pharmacy or a related life-science discipline.

• Extensive GMP experience in aseptic manufacturing, sterile operations or microbiology.

• Proven track record leading complex contamination, sterility or environmental monitoring investigations.

• Strong knowledge of EU GMP Annex 1, contamination control and aseptic processing.

• Fluent English; German and Veeva experience are advantageous.