Description

Manage and supervise complete shift production activities for API manufacturing. Execute manufacturing batches as per approved BMR, SOPs and process parameters. Monitor critical process parameters such as temperature, pressure, pH, agitation, vacuum, reaction time and material addition rates. Supervise API processes including: Raw-material and solvent charging Reaction and synthesis Heating/cooling Extraction and washing pH adjustment Distillation and solvent recovery Crystallization Filtration / centrifugation Drying Milling and sieving Ensure equipment readiness, cleaning status and line clearance before batch initiation. Verify raw materials, solvents and quantities before charging into process equipment. Coordinate with QA/QC for sampling, in-process testing, line clearance and batch-related activities. Review BMRs, equipment logbooks, shift reports and other production documentation. Monitor batch yield, cycle time, solvent consumption and process losses. Take immediate action during process abnormalities and coordinate with Engineering/Maintenance for equipment breakdowns. Lead or support investigations related to deviations, batch failures, yield variation and process abnormalities. Perform/support RCA and CAPA activities and ensure timely implementation of corrective actions. Ensure strict compliance with GMP, SOPs, EHS and data-integrity requirements. Manage operators, technicians and contract manpower during the shift. Allocate manpower and resources according to batch priorities and production requirements. Conduct effective shift handover and communicate batch status,



equipment conditions and pending activities. Coordinate with Warehouse, QA, QC, Engineering, Utilities and EHS for smooth production operations. Ensure secure handling of chemicals, solvents and hazardous materials. Enforce PPE, permit-to-work, LOTO and other applicable safety procedures. Maintain good housekeeping and ensure 5S implementation in the production area. Support process optimization, productivity improvement and reduction of manufacturing losses. Participate in shutdown, validation, qualification and process-improvement activities. Train operators and junior production personnel on SOPs, GMP, process operations and safety. Ensure production targets are achieved without compromising quality, safety or GMP compliance. Documentation & Compliance Batch Manufacturing Record (BMR) SOPs and work instructions Equipment logbooks Shift production reports Cleaning records Deviation reports Change controls CAPA documentation Safety and permit records Qualification B.E./B.Tech. – Chemical Engineering preferred. M.Sc./B.Sc. Chemistry or relevant qualification may be considered based on company requirements. Experience 5–8 years of experience in API / pharmaceutical / chemical manufacturing, preferably with substantial shift-handling and batch-process experience. Key Competencies API manufacturing process knowledge Shift management and leadership Batch process execution BMR/GMP documentation Process troubleshooting Deviation, RCA & CAPA Manpower management Production planning and target achievement Cross-functional coordination Chemical/process safety Decision-making and problem-solving

📌 Senior Executive (India)
🏢 Cadila Pharmaceuticals
📍 India