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

Ophtapharm, a Sentiss Company; Winterthur; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Benefits dieser Stelle

Pension benefits

Free parking

Public transport access

Zusammenfassung

Ophtapharm AG near Winterthur is seeking a Senior Quality Investigator for QC & Data Integrity, 80–100% FTE, to join our GMP sterile environment. You will lead complex investigations, review data and audit trails, and govern QE and Veeva portfolios with cross-functional collaboration.

The ideal candidate holds a degree in Analytical Chemistry, Pharmacy or Microbiology and has 5+ years of GMP experience, with English fluency and additional German/data analysis skills being advantageous.

Qualifikationen

• Minimum 5 years of GMP experience in pharmaceutical labs or QA.
• Experience with OOS/OOT and Data Integrity investigations.
• Fluent English; German language and data analysis skills are a plus.

Aufgaben

• Lead and drive complex QC OOS, OOT and Data Integrity investigations.
• Review laboratory data, audit trails and analyst practices to ensure 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 reporting to support improvements.

Kenntnisse

GMP experience

Data analysis

Veeva governance

Quality investigations

Excel

Power BI

Ausbildung

Analytical Chemistry / Pharmacy / Microbiology degree

Tools

Veeva

Excel

Power BI

Jobbeschreibung

Ophtapharm AG is an FDA/EU-GMP certified manufacturer in the pharmaceutical sector (ophthalmic products). At our production site near Winterthur, high-quality products such as eye drops, ointments, and gels are aseptically produced, filled, and packaged for international markets.

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.