Senior QC Investigator: Data Integrity Lead
Ophtafarm AG
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Job summary
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.
Qualifications
- 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.
Responsibilities
- 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.
Skills
Education
Tools
Job description
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.
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