Api Production Officer

Emcure; Pune District; On-site; INR 600,000 - 900,000; Full time

Job summary

Emcure is seeking a production operator with a focus on batch processing in a cGMP environment. The role involves operating API production equipment, maintaining accurate BMR/BPR and SOP documentation, and coordinating with QA/QC and maintenance teams to meet daily targets.

Candidates should have a Diploma or BE/BTech/MSc in Chemical Engineering and experience with cytotoxic drugs and solvent recovery processes. On-site role in Pune district, India.

Qualifications

• Experience with batch processing and documentation in pharmaceutical manufacturing.
• Knowledge of cGMP and safety norms.
• Experience with oncology, cytotoxic drugs, small-batch manufacturing.
• Familiar with SRP and solvent recovery processes.
• Ability to prepare and review BMRs, BPRs, SOPs and technical documents.

Responsibilities

• Handle unit operations on shop floor in shifts.
• Perform batch processing and documentation in line with cGMP and safety norms.
• Operate and monitor API production equipment (reactors, centrifuges, dryers, filters).
• Ensure on-time completion of production targets and accurate data recording.
• Coordinate with QA, QC, Warehouse, Engineering, and Maintenance for smooth operations.
• Maintain 5S and housekeeping in production area.
• Support audits and regulatory inspections with necessary documentation.

Job description

Role and Responsibilities:

• To handle unit operations on shop floor in shifts.
• To perform Batch processing & documentation, operation in line with cGMP & safety norms.
• Experience in oncology, cytotoxic drugs, small batch manufacturing.
• Experience in solvent recovery plant(SRP).
• Prepare, review and control BMRs, BPRs, SOPs, and technical documents ensuring compliance with cGMP and regulatory guidelines (USFDA, EMA); maintain document lifecycle and audit readiness.
• Execute batch manufacturing activities as per approved BMR/BPR and SOPs.
• Operate and monitor API production equipment such as reactors, centrifuges, dryers, filters, and associated utilities.
• Ensure timely completion of production activities to achieve daily and monthly production targets.
• Monitor critical process parameters and record production data accurately.
• Coordinate with QA, QC, Warehouse, Engineering, and Maintenance departments for smooth production operations.
• Ensure proper cleaning, line clearance, and equipment status maintenance.
• Investigate and report process deviations, abnormalities, and incidents.
• Maintain production documentation accurately and ensure timely completion of records.
• Participate in process improvement initiatives to enhance productivity, quality, and cost efficiency.
• Ensure housekeeping and 5S implementation in the production area.
• Support audits and regulatory inspections by providing necessary documentation and information.

Qualification :

• Diploma/ B.E/ B. Tech/M.Sc - Chemical Engineering.