Senior Officer

Execute API manufacturing processes as per approved BMR/BPR, SOPs, process parameters, and GMP requirements.
Supervise production activities involving reactors, centrifuges, filters, dryers/RCVD, and associated process equipment.
Monitor critical process parameters such as temperature, pressure, pH, reaction time, agitation, vacuum, and material charging.
Ensure proper dispensing, charging, reaction, isolation, filtration, washing, drying, milling/sieving, and packing activities as applicable.
Perform and coordinate in-process sampling and communicate with QC for testing and release of materials.
Ensure accurate and timely completion of BMR/BPR, logbooks, equipment records, checklists, and other GMP documentation.
Identify process deviations, abnormalities, and equipment issues and immediately escalate them to the concerned department.
Support investigation of deviations, OOS/OOT, incidents, and process-related failures and implement approved CAPA.
Ensure production operations are carried out according to approved procedures without unauthorized process changes.
Coordinate with QA, QC, Engineering, Warehouse, EHS, and Maintenance for smooth production operations.
Monitor raw material, solvent, consumable, and packaging-material availability for planned batches.
Ensure equipment cleaning, line clearance, status labeling, and area housekeeping are maintained as per GMP.
Follow all EHS, PPE, chemical handling, fire safety, and waste-management requirements.
Support preventive maintenance activities and report equipment breakdowns promptly.
Train and guide operators/workmen on SOPs, GMP, safety, and manufacturing practices.
Monitor batch yield, cycle time, productivity, and material consumption and highlight deviations from standard performance.
Participate in process optimization, yield improvement, cost reduction, and continuous improvement initiatives.
Support internal, customer, regulatory, and GMP audits by ensuring production areas and documentation are inspection-ready.
Maintain good housekeeping and 5S standards within the production area.
Required Qualifications
B.Sc./M.Sc. Chemistry, B.Pharm, M.Pharm, Chemical Engineering, or equivalent qualification.
2–5 years of relevant experience in API/pharmaceutical manufacturing.
Hands-on experience in chemical/API manufacturing operations is preferred.
Good knowledge of GMP, SOPs, BMR/BPR, deviation handling, and EHS requirements.
Knowledge of batch manufacturing processes and production equipment.
Good communication, documentation, problem-solving, and team-handling skills.
Key Competencies
API manufacturing process knowledge
GMP & documentation compliance
Production planning and execution
Process troubleshooting
Team supervision
Safety awareness
Deviation/CAPA understanding
Yield and productivity improvement
Cross-functional coordination
Attention to detail
Key Performance Indicators (KPIs)
Batch completion as per production plan
Batch yield and productivity
Right-first-time / documentation accuracy
GMP and audit compliance
Reduction in deviations and process losses
Equipment utilization and cycle-time adherence
Safety performance
Timely closure of production-related actions