QA Investigation Manager – Pharma Operations
vor 3 Wochen
Our customer is a major player in the biopharmaceutical industry, offering a wide range of globally established and recognized products.
As Lead Investigator you will:
- Be accountable for conducting deviation investigations until conclusion
- Follow the whole manufacturing process from bulk, packaging, warehousing and Supply
- Work in a Oral Solid Dosage Manufacturing site
- Perform complaint investigations.
Your expertise:
- Lead and conduct investigations until conclusion and ensures that the investigation outcome, root cause analysis and execution of corrective and preventive actions are completed in a timely, effective and compliance manner. Investigation scope may be related to bulk operations, packaging operations, warehouse, or maintenance processes.
- Partner with quality assurance and impacted departments (production, quality control, warehouse, maintenance, etc) to ensure investigations are exhaustive
Your skill profile:
- BS/MS in Engineering/Technical discipline or equivalent experience
- At least 2 years of experience in pharmaceutical operations, validation, packaging or related field, if possible 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
- Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.) is a nice to have.
Your solution-oriented approach allows you to communicate and negotiate in an effective way.
You have French and English fluency
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