QA Investigation Manager – Pharma Operations

8 months contract – risk assessment - CAPA

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!