Senior QC & Data Integrity Investigator
Ophtapharm, a Sentiss Company
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Benefits dieser Stelle
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
Ausbildung
Tools
Jobbeschreibung
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.
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