Process Validation Specialist
Vor 2 Tagen
We are seeking a highly skilled Process Validation Expert to join our team at Randstad. As a key member of our Fill & Finish Department, you will be responsible for leading and managing all drug product site technical activities to ensure the supply of New Biologic Entities (NBEs) and business continuity for legacy products.
Your primary objective will be to coordinate production troubleshooting and Annex 1 project-related activities. You will work closely with the Process Insight Associate Manager and other departments to establish relevant change control proposals and integrate projects into the Site Project Manager roadmap.
Key Responsibilities:
- Contribute to strategy elaboration for Annex 1 remediation
- Establish change control proposals and integrate projects into the Site Project Manager roadmap
- Ensure timely delivery of required documents and data management using QMS software and ERP systems
- Ensure compliance with GMP requirements and Health Authorities' regulations
- Participate in the establishment of raw material control strategy with suppliers and the MSAT Raw Material specialist
To succeed in this role, you will need:
- A degree in Biotechnology, Process Engineering, Pharmacy, or a related subject
- Minimum 3 years of experience in technology transfer, R&D/Manufacturing environment
- Demonstrated success record in leading projects, process improvements, and interaction with other departments
- Sound awareness of bio-pharmaceutical business and GMP related issues
- Fluent in French and English
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