Main tasks
1. Management and coordination of the QC New Product Introduction (NPI) department of quality control for the launch of new pharmaceutical products
2. Responsible for compliance with quality standards and project timelines
3. Creation and review of cGMP documents (method transfer, validation protocols, reports, work instructions, device qualification documentation)
4. Supervision of the implementation of training and analyses for the introduction of new test methods
5. Processing deviations and implementing corrective measures
6. Coordination and supervision of problem-solving activities
7. Collaboration in international analytical projects (organization/participation in international telephone conferences)
8. 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:
1. Degree in biochemistry, chemistry or comparable training
2. Professional experience in a GMP-regulated environment
3. Experience in leading diverse teams
4. Experience in working in an international matrix environment (especially in negotiating activities with multiple stakeholders)
5. Experience in method transfer/validation preferred
6. Project management experience
7. Fluent in written and spoken English and German
8. Confident handling of MS Office
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