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Quality Investigation Manager (Sterile Products) (80-100%)

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Employment type
Full-time
Location
Hettlingen
First posted
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  • 27 August 2026
  • 80 - 100%
  • Indefinite duration
  • Hettlingen CH

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 produced, filled, and packaged aseptically for international markets.

Quality Investigation Manager (Sterile Products) (80-100%) #

You play a central role in the quality assurance and compliance of sterile ophthalmic products in a highly regulated GMP environment. Acting as a key interface between Quality Assurance, Production, and Regulatory Affairs, you drive investigations and guarantee sustainable solutions.

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

Your role

  • Lead and coordinate investigations into deviations and complaints in a sterile GMP environment
  • Identify root causes and drive effective and sustainable CAPA
  • Ensure compliant and timely documentation of all investigations
  • Collaborate cross-functionally with Quality Assurance, Production, and Regulatory Affairs
  • Monitor trends and improve investigation processes and quality standards

Your profile

  • Degree in life sciences, pharmacy, chemistry, or a related field
  • More than 5 years of experience in quality investigations in sterile GMP production
  • Solid knowledge of GMP and FDA requirements for sterile products
  • Proven expertise in root cause analysis and CAPA management
  • Proficiency in English and German

What you can expect

  • Real responsibility and the opportunity to shape the conduct and improvement of investigations
  • A rapidly evolving company 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 meets challenges together
  • Flexible working conditions and a solid, reliable employment package

For recruitment agencies:

Thank you for your interest. We do not call for external support for this position.

Do you have any questions?

Our HR team is at your disposal. Tel: +41 52 304 13 23.

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Posted 4 weeks ago

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