Key duties include developing IQ/OQ/PQ protocols, managing change controls, handling deviations, training teams, and ensuring data integrity for sterile manufacturing.
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.
He must be aware of good documentation practices and aseptic behavior. Person should have hands on experience in microbiological activities such as Sterility, BET, Antibiotic assay, MLT and Culture Handling.