Pharma Operations Lead Investigator
vor 2 Wochen
Job Summary:
We are seeking a highly skilled Senior Investigator to join our team at gloor&lang AG. As a Senior Investigator, you will be responsible for conducting deviation investigations until conclusion, following the whole manufacturing process from bulk, packaging, warehousing, and supply, and performing complaint investigations.
Key Responsibilities:
- Conduct deviation investigations until conclusion, ensuring that the investigation outcome, root cause analysis, and execution of corrective and preventive actions are completed in a timely, effective, and compliance manner.
- Follow the whole manufacturing process from bulk, packaging, warehousing, and supply to identify potential issues and areas for improvement.
- Perform complaint investigations, partnering with quality assurance and impacted departments to ensure investigations are exhaustive.
Requirements:
- BS/MS in Engineering/Technical discipline or equivalent experience.
- At least 2 years of experience in pharmaceutical operations, validation, packaging, or 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.
About gloor&lang AG:
We are a leading consulting firm specializing in life sciences talent solutions. Our team of experts provides innovative and effective solutions to help our clients achieve their goals.
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