About this role
- Execute tablet coating activities as per approved BMR, SOPs, and manufacturing instructions.
- Operate and monitor coating equipment such as Auto Coater, Conventional Coater, Spray System, Peristaltic Pump, and associated equipment . Perform line clearance and verify equipment cleanliness before starting coating operations.
- Ensure correct dispensing and availability of coating solution/suspension as per batch requirements.
- Monitor and control critical coating parameters such as: Inlet and outlet temperature Product temperature Spray rate Atomization air pressure Pan speed Exhaust air/airflow Gun distance and spray pattern Monitor tablet appearance, weight gain, coating uniformity, and other in-process parameters.
- Identify and report coating defects such as picking, sticking, mottling, orange peel, bridging, twinning, chipping, and spray drying . Ensure optimum process conditions to minimize coating-related defects and batch rejection.
- B. Documentation & GMP Compliance Complete BMR, logbooks, equipment usage records, and other production documents accurately and contemporaneously.
- Follow cGMP, SOPs, Good Documentation Practices (GDP), and data integrity requirements . Ensure proper recording of process parameters and in-process checks.
- Report deviations, incidents, breakdowns, and abnormalities to the concerned supervisor/manager.
- Support investigation of deviations, OOS/OOT, process failures, and customer complaints related to coating operations.
- Ensure compliance with approved procedures and change controls.
- C. Equipment & Area Management Ensure proper operation, cleaning, and routine maintenance of coating equipment.
- Coordinate with Engineering/Maintenance for equipment breakdowns and preventive maintenance.
- Ensure proper cleaning and sanitization of coating area and equipment as per SOP.
- Verify equipment status labels and calibration status before use.
- Maintain good housekeeping and 5S practices in the coating area.