QA Investigation Manager Pharma Operations
QA Investigation Manager Pharma Operations
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Salary Not Disclosed
1 Vacancy
Job Description
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 EUGMP guidelines and GAMP
- Experienced in Health Authority inspections (preparation process presentations responses drafting etc.) is a nice to have.
Your solutionoriented approach allows you to communicate and negotiate in an effective way.
You have French and English fluency!
Employment Type
Full Time
