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

Ophtafarm AG; Hettlingen; Presencial; CHF 110.000 - 140.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Pension benefits

Free parking

Convenient public transport access

Descripción de la vacante

Ophtapharm AG in Hettlingen near Winterthur seeks a Senior Quality Investigator - QC & Data Integrity (80-100%). Lead complex QC OOS/OOT investigations, review data and audit trails, and drive Data Integrity initiatives.

Own QE and Veeva portfolio governance and ensure timely execution and escalation. You hold a degree in Analytical Chemistry, Pharmacy or Microbiology with 5+ years GMP experience in pharma labs, including aseptic manufacturing.

Formación

• Degree in Analytical Chemistry or related discipline.
• At least 5 years GMP experience in pharmaceutical lab or QA environment.
• Experience in OOS/OOT and Data Integrity investigations.
• Aseptic manufacturing or sterile GMP operations knowledge.
• Strong knowledge of analytical methods, audit trails, ALCOA+ principles and electronic quality systems.

Responsabilidades

• 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.

Conocimientos

GMP experience

OOS/OOT investigations

Data Integrity

Aseptic manufacturing

Audit trails

Veeva governance

Excel

Power BI

English fluency

German language (advantage)

Educación

Analytical Chemistry

Pharmacy

Microbiology

Herramientas

Veeva

Excel

Power BI

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.

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

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

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.

For recruitment agencies:

Thank you for your interest. We are not engaging external support for this role.

Arbeitsort

Ophtapharm AG

Riethofstrasse 1

8442 Hettlingen CH

Do you have any questions?

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