Job Description:

Execute API manufacturing batches according to approved BMRs, SOPs and production schedules.
Perform and supervise operations such as raw-material charging, reaction, heating/cooling, pH adjustment, extraction, washing, distillation, crystallization, filtration, centrifugation, drying and milling.
Monitor critical process parameters including temperature, pressure, pH, agitation, vacuum, addition rate and reaction time.
Ensure correct identification, quantity and charging of raw materials and solvents.
Verify equipment readiness, cleaning status and line clearance before starting manufacturing activities.
Coordinate with QA and QC for sampling, in-process testing and batch-related activities.
Maintain accurate and timely entries in BMRs, equipment logbooks, shift reports and other GMP documents.
Monitor batch yield, cycle time, solvent consumption and process losses.
Identify process abnormalities and coordinate with Engineering/Maintenance for equipment-related problems.
Support investigation of deviations, OOS/OOT,



yield variations and batch discrepancies wherever applicable.
Participate in RCA and CAPA implementation and follow-up.
Ensure compliance with GMP, SOPs, EHS and data-integrity requirements.
Supervise operators and contract personnel and ensure proper allocation of shift activities.
Conduct effective shift handover and communicate batch status, pending activities and equipment conditions.
Coordinate with Warehouse, QA, QC, Engineering, Utilities and EHS departments.
Ensure protected handling of chemicals, solvents and process materials and adherence to PPE requirements.
Maintain proper housekeeping and follow 5S practices in the production area.
Participate in process optimization, productivity improvement and reduction of manufacturing losses.
Train operators and junior staff on process operations, SOPs, GMP and safety practices.
API Process Exposure
Reaction and synthesis
Raw-material and solvent charging
Heating and cooling
pH adjustment

📌 Senior Officer (Mumbai)
🏢 DigiCAD
📍 Mumbai