Senior Quality Investigator - QC & Data Integrity (80-100%)

Job-Room; Hettlingen; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

Ophtapharm AG in Switzerland is seeking a Senior Quality Investigator (80-100%) to lead and govern QC/Data Integrity investigations within a sterile GMP environment. You will collaborate with QA, Manufacturing and Regulatory Affairs to drive root-cause analyses and quality improvements.

The role requires a degree in a relevant scientific discipline, 5+ years GMP experience, aseptic manufacturing exposure, and strong analytical method knowledge.

Qualifikationen

• Degree in Analytical Chemistry, Pharmacy, Microbiology or related discipline.
• 5+ years GMP experience in a pharma lab or QA environment, incl. OOS/OOT and Data Integrity investigations.
• Experience in aseptic manufacturing or sterile GMP operations.
• Strong knowledge of analytical methods, audit trails, ALCOA+ and electronic quality systems (e.g. Veeva).
• Fluent in English; German and data-analysis skills (Excel, Power BI) are an advantage.

Aufgaben

• Lead and drive complex QC OOS, OOT and Data Integrity investigations.
• Review laboratory data, audit trails and analyst practices to ensure scientifically sound conclusions.
• Own QE and Veeva portfolio governance and ensure timely execution and escalation.
• Review and approve investigations and coach investigators on quality and consistency.
• Monitor investigation trends and provide meaningful reporting to support quality improvements.

Kenntnisse

Fluent in English

German language (advantage)

Data analysis (Excel, Power BI)

Ausbildung

Degree in Analytical Chemistry, Pharmacy, Microbiology or related

Tools

Veeva

Jobbeschreibung

10 September 2026, 80 - 100%, Permanent position, 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 aseptically produced, filled, and packaged for international markets.

Senior Quality Investigator - QC & Data Integrity (80-100%)

The 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 analytical and governance-oriented professional to join us as Senior Quality Investigator - QC & Data Integrity (80-100%), starting immediately or by mutual agreement.

Your Role

• Lead and drive complex QC OOS, OOT and Data Integrity investigations.
• Review laboratory data, audit trails and analyst practices to ensure scientifically sound conclusions.
• Own QE and Veeva portfolio governance and ensure timely execution and escalation.
• Review and approve investigations and coach investigators on quality and consistency.
• Monitor investigation trends and provide meaningful reporting to support quality improvements.

Your Profile

• Degree in Analytical Chemistry, Pharmacy, Microbiology or a related scientific discipline.
• At least 5 years of GMP experience in a pharmaceutical laboratory or QA environment, including OOS/OOT and Data Integrity investigations.
• Experience in aseptic manufacturing or sterile GMP operations.
• Strong knowledge of analytical methods, audit trails, ALCOA+ principles and electronic quality systems (e.g. Veeva).
• Fluent in English; German and data analysis skills (Excel, Power BI) are an advantage.

What you can expect

• A central role improving the scientific quality and operational control of Ophtapharm-s investigation portfolio.
• Ownership of complex laboratory and Data Integrity investigations, with visible responsibility for QE/Veeva governance.
• The opportunity to build reliable portfolio reporting and strengthen investigator capability across functions.
• Close collaboration with QA, QC, Manufacturing, IT, Regulatory Affairs and senior quality leadership.
• Attractive employment conditions, including pension benefits, free parking and convenient public transport access.