Senior Quality Investigator – QC & Data Integrity

Lead and drive complex QC OOS, OOT and Data Integrity investigations. Review laboratory data, audit trails and analyst practices to ensure scientifically sound conclusions. Own QE and Veeva portfolio governance and ensure timely execution and escalation. Review and approve investigations and coach investigators on quality and consistency. Monitor investigation trends and provide meaningful reporting to support quality improvements.

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. The 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 Analytical Chemistry, Pharmacy, Microbiology or a related scientific discipline.

• At least 5 years of GMP experience in a pharmaceutical laboratory or QA environment, including OOS/OOT and Data Integrity investigations.

• Experience in aseptic manufacturing or sterile GMP operations.

• Strong knowledge of analytical methods, audit trails, ALCOA+ principles and electronic quality systems (e.g. Veeva).

• Fluent in English; German and data analysis skills (Excel, Power BI) are an advantage.