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Quality Investigations Lead (Sterile Products) – 80-100%

Ophtapharm AG
1 day ago
Full-time
On-site
Zürich, ZH

JobsCloseBy Editorial Insights

Ophtapharm AG seeks a Quality Investigations Lead (Sterile Products) for 80-100% onsite at our Hettlingen site near Winterthur to safeguard quality in a GMP environment for ophthalmic products. You will lead deviation and complaint investigations, identify root causes, drive sustainable CAPAs, ensure timely compliant documentation, and collaborate with QA and Manufacturing while monitoring trends to raise standards. The ideal candidate has 5+ years in quality investigations within sterile GMP manufacturing, strong GMP and FDA knowledge for sterile products, proven RCA and CAPA expertise, and fluency in English and German. To apply, tailor your CV to show measurable improvements in investigation timelines and CAPA outcomes, highlight cross-functional impact, and prepare to discuss ownership. No external recruitment agencies; questions to HR at +41 52 304 13 23.

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.