Job Description

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 Lead (Sterile Products) (80-100%)

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.

We are looking for an analytical and solution-oriented professional to join our team as Quality Investigations Lead (80–100%) near Winterthur.

Your Role

• 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

Your Profile

• 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

What you can expect

• 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

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.