Key Responsibilities:

• Operate and monitor lyophilization (freeze-drying) equipment for injectable products.
• Load and unload vials into/from lyophilizers under aseptic conditions.
• Monitor critical process parameters such as temperature, pressure, and cycle time.
• Execute lyophilization cycles as per BMR and validated parameters.
• Perform line clearance before and after operations.
• Ensure compliance with GMP, SOPs, and aseptic practices.
• Coordinate with QA/IPQA for in-process checks and approvals.
• Record and maintain batch documentation and logbooks.
• Identify and report deviations, incidents, and implement CAPA.
• Ensure cleaning, sterilization, and maintenance of equipment.