Job Description

Execute API manufacturing batches as per approved Batch Manufacturing Records (BMRs) and SOPs. Monitor manufacturing processes such as charging, reaction, heating/cooling, extraction, filtration, centrifugation, distillation, drying, milling, and packing, as applicable. Monitor critical process parameters including temperature, pressure, pH, vacuum, agitation, addition rate, and reaction time. Ensure manufacturing activities are performed within approved process parameters. Monitor batch progress, yield, cycle time, and material consumption. Identify process abnormalities and immediately inform the Production Manager/shift in-charge. Ensure timely completion of batches as per the production plan. Complete BMRs, equipment logbooks, cleaning records, checklists, and other production documents accurately and on time. Follow cGMP, SOPs, GDP, data-integrity, and safety requirements. Ensure proper line clearance, equipment status identification, and area readiness. Report and support investigation of deviations, yield variations, process failures, and other manufacturing incidents. Support implementation of CAPA, change controls, and corrective actions. Maintain production areas in an audit-ready condition. Complete BMRs, equipment logbooks, cleaning records, checklists, and other production documents accurately and on time. Follow cGMP, SOPs, GDP, data-integrity, and safety requirements. Ensure proper line clearance, equipment status identification, and area readiness. Report and support investigation of deviations, yield variations, process failures, and other manufacturing incidents. Support implementation of CAPA, change controls, and corrective actions. Maintain production areas in an audit-ready condition.


Job Details

Role Level: Associate Work Type: Full-Time
Country: India City: Dahej ,Gujarat
Company Website: http://www.cplltd.com Job Function: Administrative Support
Company Industry/
Sector:
Pharmaceutical Manufacturing

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