Senior Quality Investigator - Sterile Manufacturing & Microbiology (80-100%)

Ophtafarm AG; Hettlingen; Presencial; CHF 130.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Pension benefits

Free parking

Public transport access

Descripción de la vacante

Ophtapharm AG in Hettlingen near Winterthur is seeking an experienced Senior Quality Investigator - Sterile Manufacturing & Microbiology (80-100%). You will lead major investigations related to sterility, contamination, environmental monitoring and aseptic operations, and define investigation strategies with SMEs and the FvP.

You will review and approve investigations, support audits and inspections, and coach investigators on complex cases.

Formación

• Degree in Microbiology, Biology, Pharmacy or related life-science discipline.
• Extensive GMP experience in aseptic manufacturing, sterile operations or microbiology.
• Fluent English; German and Veeva experience are advantageous.

Responsabilidades

• Lead major investigations related to sterility, contamination, environmental monitoring and aseptic operations.
• Define investigation strategies, containment measures and sampling plans with SMEs and the FvP.
• Review and approve investigations, and coach investigators on complex cases.
• Support audits and inspections.

Conocimientos

GMP knowledge

Investigations leadership

Environmental monitoring

Educación

Degree in Microbiology, Biology, Pharmacy or related life-science

Herramientas

Veeva

Descripción del empleo

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 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.

Senior Quality Investigator - Sterile Manufacturing & Microbiology (80-100%)

Your Role

• 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.

Your Profile

• 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.

What you can expect

• 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.

Arbeitsort

Ophtapharm AG
Riethofstrasse 1
8442 Hettlingen CH

Do you have any questions?

Our HR team is happy to assist you. Tel: [phone].