Senior QC & Data Integrity Investigator

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

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.