Lead Investigator

vor 3 Wochen

YverdonlesBains, Waadt, Schweiz gloor&lang AG Vollzeit
8 months contract – risk assessment - CAPA

Contribute to a leading biopharmaceutical company

As a Lead Investigator, you will oversee deviation investigations from start to finish, ensuring timely and effective outcomes. You will collaborate with quality assurance and impacted departments to guarantee a comprehensive approach.

Your role

  • Conduct root cause analysis and execute corrective actions in compliance with regulations.
  • Partner with production, quality control, and maintenance teams to ensure thorough investigations.

Your expertise

  • Lead and conduct investigations, ensuring timely and effective completion.
  • Collaborate with quality assurance and impacted departments to guarantee a comprehensive approach.

Your profile

  • BS/MS in Engineering/Technical discipline or equivalent experience.
  • At least 2 years of experience in pharmaceutical operations, validation, packaging, or a related field, preferably in Oral Solid Dosage manufacturing.
  • Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes.
  • Sound knowledge of current international regulatory regulations, cGxP requirements, and best practices, including 21 CFR part 11, 210, and 211, Annex 11, EU-GMP guidelines, and GAMP.
  • Fluency in French and English.

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