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CQV Lead
vor 2 Wochen
We are seeking an experienced CQV Lead to support our client's pharmaceutical project in Basel.
As the CQV Lead, you will be responsible for leading and coordinating all CQV activities, ensuring full compliance with GMP and regulatory requirements. This role requires hands-on leadership, deep technical understanding of lyophilization processes, and the ability to drive collaboration across engineering, quality, and operations.
Key Responsibilities
- Management and coordination of C&Q activities across project phases
- Interface management between Engineering, Quality, Production, and external partners
- Coordination of documentation: creation, review, and approval of C&Q documents including URS, DQ, IQ, OQ, and PQ.
- Leading C&Q teams an coordinating external service providers
- Promoting best practices and continuous improvement in CQV methodologies, documentation standards, and project execution.
- Support FAT/SAT and performance qualification for lyophilizers and associated equipment
Requirements
- Proven expertise with lyophilizers / freeze-dryers
- Demonstrated ability to lead CQV teams or manage external partners on complex projects.
- Excellent communication, coordination, and stakeholder management skills
- Ideally German speaking
