Essential Functions Operate and monitor equipment used in various stages of API production such as reactors centrifuges dryers millers sifters etc Ensure cleanliness and readiness of equipment before batch charging through visual verification procedures Maintain accurate records including Batch Manufacturing Record BMR Batch Cleaning Record BCR Batch Packing Record BPR equipment usage logs and deviation reports Execute batch operations strictly as per SOPs and GMP guidelines Monitor and record process parameters in real-time to ensure adherence to specifications and quality Report and coordinate with Engineering for any equipment breakdowns during the shift Coordinate with QA for issuance and submission of documents and with the warehouse for material movement Handle raw materials intermediates and APIs ensuring proper storage reconciliation and documentation Follow standard procedures for sampling and in-process testing of materials and intermediates Maintain cleanliness and good housekeeping in the designated manufacturing area Monitor utilities in the plant e g steam vacuum chilled water and report abnormalities Monitor and record environmental conditions like temperature humidity and differential pressure in clean areas Level-I II III Perform daily verification and calibration checks of weighing balances Participate in periodic equipment cleaning and preventive maintenance Ensure proper handling and disposal of hazardous materials as per environmental guidelines Identify process deviations malfunctions or quality concerns and report them immediately Support continual improvement by suggesting ideas for optimization efficiency and waste reduction Take mandatory safety and operational training via AIMS software and participate in hands-on skill-building sessions Adhere strictly to safety practices and use PPE as per company safety protocols Participate in emergency response activities such as managing spills or operational incidents Ensure timely inventory of plant process-related consumables Review completed manufacturing records for accuracy completeness and compliance with SOPs Additional Responsibilities Support implementation of process improvement initiatives and lean manufacturing practices Assist in the qualification and validation of equipment and processes as per regulatory and internal guidelines Ensure readiness of the area for internal external and regulatory audits Support investigation and documentation of deviations change controls and CAPAs in coordination with QA Participate in cross-functional meetings to discuss production schedules quality concerns and improvement plans Maintain discipline and GMP compliance on the shop floor and promote a culture of accountability Train and mentor junior staff operators on standard procedures and protected working practices Assist in preparation and review of SOPs related to manufacturing activities Support periodic review of equipment performance and suggest improvements for efficiency Ensure adherence to environmental and safety norms in chemical handling and waste disposal Actively participate in safety drills risk assessments HIRA and incident investigations Coordinate with stores for timely availability of raw materials consumables and packing materials Report daily production updates to the shift in-charge or supervisor as required Qualifications - Education Master Degree M Sc - Organic Chemistry - Preferred Bachelor Degree B Pharma - Preferred B E Chemical - Required B Tech Chemical - Required Experience 4 to 6 years in API Intermediate manufacturing operations Skills API Manufacturing Operations - Intermediate to Advanced Batch Documentation BMR BCR BPR - Intermediate GMP Compliance and Data Integrity - Intermediate Process Monitoring and Troubleshooting - Intermediate SOP Adherence and Equipment Operation - Intermediate Safety and Emergency Response - Intermediate Material Handling Inventory Control - Basic to Intermediate Utilities Cleanroom Parameter Monitoring - Basic Team Coordination and Communication - Intermediate Qualifications - Education Master Degree M Sc - Organic Chemistry - Preferred Bachelor Degree B Pharma - Preferred B E Chemical - Required B Tech Chemical - Required Experience 2 to 5 years in API Intermediate manufacturing operations