Senior Quality Investigator — QC & Data Integrity Lead

Ophtapharm AG; Hettlingen; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Benefits dieser Stelle

Pension benefits

Free parking

Public transport access

Zusammenfassung

Ophtapharm AG in Switzerland seeks a Senior Quality Investigator to lead QC OOS, OOT and Data Integrity investigations in a GMP environment. You will review lab data, audit trails and analyst practices, while driving QE and Veeva governance and providing training to investigators.

The role emphasizes analytical rigor and governance orientation, with collaboration across QA, Manufacturing and Regulatory Affairs.

Qualifikationen

• Degree in Analytical Chemistry, Pharmacy, Microbiology or related field.
• At least 5 years GMP experience in a pharmaceutical laboratory or QA environment.
• Experience in OOS/OOT and Data Integrity investigations.
• Strong knowledge of electronic quality systems (Veeva) and ALCOA+ principles.

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

Analytical mindset

Governance

Ausbildung

Analytical Chemistry degree

Pharmacy degree

Microbiology degree

Tools

Veeva

Excel

Power BI

Jobbeschreibung

Ophtapharm AG in Switzerland seeks a Senior Quality Investigator to lead QC OOS, OOT and Data Integrity investigations in a GMP environment. You will review lab data, audit trails and analyst practices, while driving QE and Veeva governance and providing training to investigators.

The role emphasizes analytical rigor and governance orientation, with collaboration across QA, Manufacturing and Regulatory Affairs.