Officer

Role Objective / Major Purpose of the Job

 Production API is responsible for executing day-to-day API manufacturing activities in accordance with approved Batch
Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), cGMP, EHS, and regulatory requirements. The role
supports smooth production operations by ensuring accurate documentation, safe equipment operation, process compliance, and
coordination with cross-functional teams to achieve production and quality objectives.

Production Operations
 Execute API manufacturing activities as per approved Batch Manufacturing Records (BMRs), SOPs, and production schedules.
 Operate and monitor reactors, centrifuges, dryers, filters, and other process equipment safely and efficiently.
 Verify the availability of raw materials, intermediates, and production equipment before batch initiation.
 Perform line clearance before commencement and after completion of each production batch.
 Monitor critical process parameters and report any deviations or abnormalities to the Production Officer/Executive.
 Ensure timely completion of assigned manufacturing activities while maintaining quality standards.
 Assist in batch charging, filtration, centrifugation, drying, blending, and material transfer activities.

Key Skills & Competencies
Functional / Technical:
 -Basic knowledge of API manufacturing processes
 -Knowledge of cGMP, GDP, SOPs, and regulatory compliance
 -Batch Manufacturing Record (BMR) documentation
 -Reactor, centrifuge, dryer, filter, and process equipment operation
 -Basic chemical process and reaction knowledge
 -Basic SAP/ERP knowledge

 -Process monitoring and basic troubleshooting
 -Knowledge of process validation and equipment qualification
 -EHS practices and hazardous chemical handling
 -MS Office applications
Behavioural:
 - Teamwork and Collaboration
 -Good Communication Skills
 -Learning Agility
 -Attention to Detail
 -Problem Solving