Ophtapharm AG
Hettlingen CH
Senior Quality Investigator – QC & Data Integrity (80-100%)
- 10 September 2026
- 80 – 100%
- Permanent position
- Hettlingen CH
Job summary
Join Ophtapharm AG, a certified pharmaceutical manufacturer, in Hettlingen. Be part of a dynamic team committed to quality and compliance.
Tasks
- Lead complex investigations in QC, OOS, and OOT processes.
- Review lab data and audit trails for sound scientific conclusions.
- Coach investigators and monitor trends for quality improvements.
Skills
- Degree in Analytical Chemistry, Pharmacy, or related field; 5+ years GMP experience.
- Strong knowledge of analytical methods and electronic quality systems.
- Fluent in English, with data analysis skills in Excel and Power BI.
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About the job
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.
Senior Quality Investigator – QC & Data Integrity (80-100%)
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.
To support the ongoing development of our Quality Investigations team, we are looking for an analytical and governance-oriented professional to join us as Senior Quality Investigator – QC & Data Integrity (80–100%), starting immediately or by mutual agreement.
Your Role
- 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.
Your Profile
- 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.
What you can expect
- A central role improving the scientific quality and operational control of Ophtapharm’s investigation portfolio.
- Ownership of complex laboratory and Data Integrity investigations, with visible responsibility for QE/Veeva governance.
- The opportunity to build reliable portfolio reporting and strengthen investigator capability across functions.
- Close collaboration with QA, QC, Manufacturing, IT, Regulatory Affairs and senior quality leadership.
- Attractive employment conditions, including pension benefits, free parking and convenient public transport access.
Thank you for your interest. We are not engaging external support for this role.
Do you have any questions?
Our HR team is happy to assist you. Tel: +41 52 304 13 23.
