Lead Investigator
Vor 4 Tagen
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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