The role is within the Clinical Supply Quality team, focusing on packaging and labeling for clinical studies. The position is critical for ensuring quality systems and compliance in the production, release, and distribution of Investigational Medicinal Products (IMPs) for clinical trials. - System-related activities: deviation review, CAPA (Corrective and Preventive Actions), change control. - Familiarity with regulatory submissions and CMC (Chemistry, Manufacturing, and Controls) documentation.
meer