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Process Validation Specialist
vor 2 Monaten
The MSAT DP within the Fill & Finish Department at Randstad (Schweiz) AG is 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, in compliance with specifications, registration, and GMP requirements.
We are seeking a Process Validation Expert to join our team.
Key Responsibilities:
- Coordinate technical transfer, process validation, and commercial manufacturing campaign activities
- Support production troubleshooting and investigation, as needed
- Collaborate with Pharmaceutical Development entities
- Train Aubonne site personnel
- Conduct internal and external audits
Who We're Looking For:
- Degree in Biotechnology, Process Engineering, Pharmacy, or related field
- Minimum 3 years of experience in technology transfer, R&D/Manufacturing environment
- Proven success in leading projects, using project management tools, and process improvements
- Strong awareness of bio-pharmaceutical business
- Strong awareness of GMP-related issues and Health Authorities' requirements
- Fluent in French and English
