<ul><li>Perform all production activities inside classified cleanrooms following strict aseptic techniques and gowning procedures.</li><li>Operate sterile filling, sealing, and capping machines for vials, ampoules, or pre-filled syringes.</li><li>Monitor critical process parameters (e.g., fill volume, stopper seating, seal integrity) during sterile operations.</li><li>Execute production batches as per approved Batch Manufacturing Records (BMRs) and detailed SOPs.</li><li>Ensure accurate, legible, and contemporaneous completion of all entries in BMRs, logbooks, and related documentation.</li><li>Perform line clearances, material reconciliation, and yield calculations for each batch.</li><li>Assemble and dismantle equipment parts ensuring proper sanitation.</li><li>Coordinate with Engineering/Maintenance for preventive maintenance and breakdown repairs of sterile manufacturing equipment.</li></ul>

Production Sterile Injectable Technician