Senior Officer

Cadila Pharmaceuticals Limited; Mumbai; On-site; INR 900,000 - 1,300,000; Full time

Benefits offered by this job

Health insurance

Job summary

Cadila Pharmaceuticals Limited in Mumbai is seeking qualified personnel to execute and monitor API manufacturing activities in line with approved BMRs, SOPs, and cGMP guidelines. The role emphasizes safety, product quality, and achieving production targets.

You will supervise batch processing, monitor key process parameters, ensure proper documentation, and coordinate with shift teams to drive on-time completion and continuous improvement.

Qualifications

• Qualifications in chemistry or chemical process operations as per company requirements.
• Experience in API manufacturing and batch processing is preferred.

Responsibilities

• Execute batch manufacturing activities as per approved BMRs and production schedules.
• Supervise day-to-day operations: charging, reactions, distillation, extraction, filtration, drying, milling, and packing.
• Monitor process parameters: temperature, pressure, pH, agitation, reaction time, vacuum.
• Ensure traceability of raw materials, intermediates, and finished products; report deviations promptly.
• Coordinate with production supervisors and operators to meet daily targets.
• Monitor batch progress and report abnormalities to the reporting manager.

Skills

API manufacturing processes

Chemical reactions

GMP documentation

Data integrity

Shift readiness

Education

B.Sc./M.Sc. in Chemistry

B.E./B.Tech in Chemical Engineering

Job description

To execute and monitor API manufacturing activities as per approved Batch Manufacturing Records (BMRs), SOPs, cGMP guidelines, and safety procedures, ensuring product quality, production targets, batch yield, and timely completion of manufacturing operations.

Key Responsibilities

A. Production Operations

• Execute batch manufacturing activities as per approved BMRs and production schedules.
• Supervise day-to-day operations such as raw material charging, chemical reactions, distillation, extraction, filtration, centrifugation, drying, milling, and packing.
• Monitor process parameters such as temperature, pressure, pH, agitation, reaction time, and vacuum.
• Ensure proper handling, identification, and traceability of raw materials, intermediates, and finished products.
• Coordinate with production supervisors and operators to achieve daily production targets.
• Monitor batch progress and report abnormalities to the reporting manager.

B. GMP and Documentation

• Follow cGMP requirements, SOPs, safety instructions, and data integrity practices.
• Maintain accurate and timely entries in BMRs, equipment logbooks, and cleaning records.
• Ensure line clearance, equipment status labeling, and cleaning verification before starting operations.
• Report deviations, process abnormalities, and incidents promptly.
• Support deviation investigations, CAPA implementation, and audit readiness.
• Ensure compliance with applicable regulatory and company requirements.

C. Process Monitoring and Yield Improvement

• Monitor batch yield, cycle time, solvent consumption, and material utilization.
• Identify process variations and communicate them to the production manager.
• Assist in troubleshooting manufacturing problems and minimizing process losses.
• Support process validation, technology transfer, and process improvement activities.
• Ensure proper recovery and reuse of solvents wherever approved procedures permit.

D. Equipment and Maintenance

• Ensure equipment readiness before batch initiation.
• Monitor the operation of reactors, centrifuges, dryers, filters, pumps, and other manufacturing equipment.
• Coordinate with engineering and maintenance teams for equipment breakdowns.
• Follow preventive maintenance, calibration, and equipment cleaning requirements.
• Ensure proper equipment status identification and logbook maintenance.

E. Safety and Environmental Compliance

• Follow EHS guidelines and ensure appropriate PPE usage.
• Handle chemicals, solvents, and hazardous materials according to approved procedures.
• Follow permit-to-work requirements and established safety precautions.
• Report unsafe conditions, near misses, and incidents to the concerned department.
• Follow waste disposal, solvent handling, and environmental protection procedures.

F. Team Coordination

• Guide operators and production personnel during routine manufacturing activities.
• Allocate and monitor assigned tasks during shifts.
• Train operators on SOPs, GMP, equipment operation, and safety practices.
• Coordinate with QA, QC, stores, engineering, and utility departments.
• Support shift handovers and communicate batch status, pending activities, and equipment issues.

Qualification

• B.Sc./M.Sc. in Chemistry or B.E./B.Tech in Chemical Engineering.
• Relevant qualification in chemistry or chemical process operations as per company requirements.

Experience

• Typically 4–8 years of experience in API manufacturing.
• Hands‑on experience in chemical synthesis, batch processing, and production documentation.
• Working knowledge of cGMP, BMRs, SOPs, equipment handling, and industrial safety.

Required Skills

• Knowledge of API manufacturing processes and chemical reactions.
• Understanding of GMP documentation and data integrity.
• Basic troubleshooting and process monitoring skills.
• Team coordination, communication, and reporting skills.
• Ability to work in shifts and meet production schedules.

Key Performance Indicators (KPIs)

• Achievement of assigned production targets.
• Batch yield and cycle time performance.
• Accuracy and completeness of BMR documentation.
• Compliance with GMP, SOPs, and EHS requirements.
• Reduction in process losses and equipment downtime.
• Timely reporting of deviations and completion of assigned CAPAs.
• Training compliance and housekeeping standards.

Note: This JD can be customized based on the specific API process, manufacturing facility, and company requirements.