12 Oct
|
GUFIC BIOSCIENCES
|
Indore
12 Oct
GUFIC BIOSCIENCES
Indore
Operate and monitor Lyophilizer (Lyo) equipment as per approved SOPs and batch manufacturing records.
Perform loading and unloading of sterile products/trays into the lyophilizer as per defined procedures.
Monitor critical process parameters such as shelf temperature, product temperature, chamber pressure, vacuum, condenser temperature, and cycle parameters.
Execute lyophilization cycles as per approved recipes and manufacturing instructions.
Perform equipment line clearance and ensure the equipment and surrounding area are ready before operation.
Check equipment status, utilities, alarms, and operating conditions before and during the batch.
Record process parameters and observations accurately in BMR/BPR, logbooks, and relevant documents.
Follow cGMP, SOPs, aseptic practices, data integrity, and safety requirements.
Carry out cleaning and sanitization of the lyophilizer and associated equipment as per approved procedures.
Coordinate with Production, QA, Engineering, and Maintenance teams for smooth execution of batches.
Report equipment abnormalities, process deviations, breakdowns, and other issues to the concerned supervisor.
Assist in troubleshooting operational issues related to the lyophilizer.
Ensure proper handling of sterile products during loading, unloading, and transfer activities.
Maintain housekeeping and comply with 5S and EHS requirements.
Participate in qualification, validation, preventive maintenance, and equipment-related activities when required.
Ensure all activities are performed in accordance with applicable GMP and regulatory requirements.
📌 Lyophilizer Operator Indore
🏢 GUFIC BIOSCIENCES
📍 Indore