Ophtapharm AG is an FDA/EU-GMP certified manufacturer in the pharmaceutical sector (ophthalmic products). At the 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. You play a central role in ensuring quality and compliance for sterile ophthalmic products in a highly regulated GMP environment. Acting as a key interface across QA, Manufacturing, and Regulatory Affairs, you drive investigations and ensure sustainable solutions.
Tasks
- 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
Requirements
- 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
Benefits
- Real ownership and the opportunity to shape how investigations are run and improved
- A company on a journey where change is real and your impact is visible
- Direct access to decision-makers and cross-functional influence
- A committed team that takes responsibility and works through challenges together
- Flexible working conditions and a solid, dependable employment package
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Über uns
Das Team
A committed team that takes responsibility and works through challenges together.