Ophtapharm AG
Hettlingen CH
Senior Quality Investigator – Sterile Manufacturing & Microbiology (80-100%)
- 10 October 2026
- 80 – 100%
- Permanent position
- Hettlingen CH
Job summary
Ophtapharm AG is an FDA/EU-GMP certified manufacturer of ophthalmic products. Join a dynamic team for impactful work in sterile manufacturing.
Tasks
- Lead critical investigations on sterility and contamination issues.
- Define strategies and containment measures with SMEs for investigations.
- Review investigations ensuring compliance and scientific rigor.
Skills
- Degree in Microbiology, Pharmacy, or related life-science field required.
- Extensive GMP experience in aseptic manufacturing or microbiology.
- Strong knowledge of EU GMP Annex 1 and contamination control.
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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 – Sterile Manufacturing & Microbiology (80-100%)
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 experienced and autonomous professional to join us as Senior Quality Investigator – Sterile Manufacturing & Microbiology (80–100%), starting immediately or by mutual agreement.
Your Role
- 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.
Your Profile
- 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.
What you can expect
- A high-impact role protecting product quality and patient safety in sterile ophthalmic manufacturing.
- Ownership of critical sterility and microbiology investigations, including QA approval authority.
- The opportunity to shape investigation standards and contamination control practices.
- Close collaboration with QA, QC/Microbiology, Manufacturing and Regulatory Affairs.
- Attractive employment conditions, including pension benefits, free parking and public transport access.
For recruitment agencies:
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.
