Ophtapharm AG
Hettlingen CH
Senior Quality Investigator – Sterile Manufacturing & Microbiology (80-100%)
- 10 September 2026
- 80 – 100%
- Permanent position
- Hettlingen CH
Job summary
Join Ophtapharm AG, a certified pharmaceutical manufacturer, producing quality ophthalmic products. This role offers a collaborative environment and great benefits.
Tasks
- Lead investigations into sterility and contamination issues in manufacturing.
- Develop strategies for containment and sampling in aseptic processes.
- Review investigations to ensure compliance and scientific integrity.
Skills
- Degree in Microbiology, Biology or Pharmacy with GMP experience.
- Expertise in aseptic manufacturing and contamination control.
- Strong knowledge of EU GMP regulations and fluent in English.
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About the job
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.
- 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.
- 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.
- 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.
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