Execute and supervise compounding activities for sterile injectable products as per approved BMRs, SOPs, and manufacturing procedures.
Perform dispensing/charging of raw materials and excipients as per approved manufacturing instructions.
Operate and monitor manufacturing vessels, compounding tanks, mixing systems, filtration systems, and associated equipment.
Perform and monitor CIP and SIP activities of manufacturing vessels and associated systems.
Carry out aseptic filtration and filtration-related activities as per approved procedures.
Monitor critical process parameters such as temperature, pressure, pH, conductivity, mixing time, and other applicable parameters.
Perform required in-process checks during compounding and filtration operations.
Ensure proper cleaning, sanitization, and maintenance of the compounding and filtration areas.
Maintain Batch Manufacturing Records (BMRs), equipment logbooks, cleaning records, and other GMP documentation accurately and in real time.
Ensure compliance with cGMP, SOPs, safety procedures, and contamination-control practices.
Handle and operate equipment such as weighing balances, pH meters, conductivity meters, filtration vessels, compounding vessels, CIP/SIP systems, and related manufacturing equipment.
Coordinate with QA, QC, Warehouse, Engineering, and other cross-functional teams for smooth execution of manufacturing activities.
Support equipment calibration, qualification, validation, and preventive-maintenance activities.
Report and support investigation of deviations, incidents, process abnormalities, and equipment-related issues.
Ensure proper line clearance, area readiness, and equipment readiness before commencement of batches.
Support media fill and other aseptic manufacturing activities, wherever applicable.
Follow good documentation practices and ensure data integrity in all manufacturing records.
Participate in internal and regulatory audit/inspection activities as required.
Follow all company EHS and safety requirements.
Contribute to continuous improvement, productivity enhancement, and reduction of manufacturing deviations.
