Cqv Lead

Vor 2 Tagen

Visp, Schweiz PSC Biotech Ltd Vollzeit

CQV Lead (Switzerland, Visp)

PSC Biotech is recruiting CQV Lead for our client, a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

PSC Biotech Ltd is looking for a Commissioning, Qualification and Validation (CQV) Lead.

Key Responsibilities
- Responsible to apply/implement Commissioning, Qualification and Validation (CQV) approach, standardized CQV procedures and provide oversight on CQV activities of Lonza’s CAPEX projects at a SGIE project level.
- Responsible for ensuring that SGIE projects are compliant with the global CQV guidelines, aligned with local/site level procedures and detect/resolve potential gaps in line with Lonza’s continuous improvement vision.
- Leverage work being done at global level, to engage specialized companies for CQV activities to support SGIE CAPEX projects.
- Ensure CQV activity compliance with all pertinent safety policies, rules and regulations.
Key Requirements
- Solid experience in Commissioning, Qualification and Validation incl. CSV with good experience in management of pharmaceutical projects. Familiarity with biologics (mammalian, CGT) as well as chemical manufacturing technologies desirable
- Profound experience in regulated pharmaceutical industry and/or engineering company
- Knowledge of ISPE guidelines with proven experience on projects. Proven experience in an EMA / FDA regulated environmental with good knowledge of current ICH, PIC/S, EU and US regulatory requirements and their implementation.
- Experience in People Management (internal and external) with respect to organizational aspects, coaching and project management
- Language: Good command of English and proven knowledge in German necessary

Schedule:

- Monday to Friday

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