Job Description

Role & responsibilities Conduct in-process checks during various stages of sterile injectable manufacturing, including dispensing, compounding, filtration, filling, and sealing. Perform line clearance and area clearance before the start of manufacturing and packaging operations. Monitor aseptic practices and personnel hygiene compliance inside cleanrooms and controlled areas. Verify critical process parameters and environmental conditions during batch processing. Ensure compliance with SOPs, batch manufacturing records (BMR), and batch packaging records (BPR). Participate in visual inspection activities and oversee container-closure integrity checks. Monitor the usage and replacement of sterilized garments, materials, and equipment in aseptic areas. Raise deviations, non-conformances, and change controls as needed. Assist in investigations for OOS, OOT, or any batch-related quality issues. Provide training to operators and workers on GMP, GDP, and aseptic technique