Sr. Manager QC NPI
Vor 5 Tagen
Main tasks
- Management and coordination of the QC New Product Introduction (NPI) department of quality control for the launch of new pharmaceutical products
- Responsible for compliance with quality standards and project timelines
- Creation and review of cGMP documents (method transfer, validation protocols, reports, work instructions, device qualification documentation)
- Supervision of the implementation of training and analyses for the introduction of new test methods
- Processing deviations and implementing corrective measures
- Coordination and supervision of problem-solving activities
- Collaboration in international analytical projects (organization/participation in international telephone conferences)
- Participation in audits and inspections in connection with the introduction of new products into quality control
Your profile
For this interesting and varied position, we are looking for a team player, communicative and proactive personality with a high degree of quality awareness, resilience and flexibility. You are characterized by an independent, precise and goal-oriented way of working as well as reliability and adherence to deadlines. You also have the following professional qualifications:
- Degree in biochemistry, chemistry or comparable training
- Professional experience in a GMP-regulated environment
- Experience in leading diverse teams
- Experience in working in an international matrix environment (especially in negotiating activities with multiple stakeholders)
- Experience in method transfer/validation preferred
- Project management experience
- Fluent in written and spoken English and German
- Confident handling of MS Office
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