Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies.
Ensure compliance with global and local procedural documents and local implementation of Patient Safety objectives, policies, processes and procedures.
Exposure to OSD Manufacturing operations like Compression, Pellet coating, Capsule filling, Primary Packing & Secondary Packing. Expertise in e-BPR and e-log will be added advantage.
B. Pharmacy, M. Pharmacy, M.Sc, B.Sc, Diploma with relevant functional experience in injectable manufacturing, Aseptic area operations, Visual inspection, QMS activities