Production Chemist / Production Officer - API Pharmaceutical

Enaltec; Mumbai, Ambernath; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Enaltec in Mumbai, India, is seeking an experienced API production professional to execute manufacturing activities and ensure GMP compliance. You will handle reactors, distillations, and related operations, while maintaining accurate batch records and material reconciliation.

The role requires a strong background in chemistry and at least 15 years in API/pharmaceutical chemical manufacturing, with the ability to coordinate with QC/QA, Engineering, Warehouse, and EHS to ensure smooth operations.

Qualifications

• 15 years of experience in API production or pharmaceutical chemical manufacturing.
• Qualifications include B.Sc./M.Sc. Chemistry, B.Pharm or M.Pharm as per company requirements.
• Experience requirements may vary by designation.

Responsibilities

• Execute API manufacturing activities per approved BMRs and SOPs.
• Perform raw material charging, reactor operation, and related processes.
• Complete BMRs, equipment logbooks, and GMP-compliant records.
• Operate and monitor reactors and production equipment per procedures.
• Monitor critical process parameters and report deviations.
• Ensure cGMP and safety compliance across operations.
• Verify materials and ensure traceability of process materials.
• Maintain cleanliness and follow chemical safety procedures.
• Record batch yields and material reconciliation.
• Coordinate with QC/QA, Engineering, Warehouse, and EHS for production.

Education

B.Sc. Chemistry

M.Sc. Chemistry

B.Pharm

M.Pharm

Tools

GMP compliance

Safety procedures

Process monitoring

Job description

Role & responsibilities

1. Production Operations: Execute API manufacturing activities as per approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), and established manufacturing procedures.
2. Process Handling: Perform manufacturing operations such as raw material charging, reactor operation, chemical reactions, distillation, filtration, centrifugation, drying, and material transfer, as applicable to the process.
3. Batch Documentation: Complete BMRs, equipment logbooks, process records, and other production documents accurately and in compliance with Good Manufacturing Practices (GMP).
4. Equipment Operation: Operate and monitor reactors like SSR,GLR, centrifuges, dryers, filters, condensers, and other production equipment as per approved procedures.
5. Process Monitoring: Monitor critical process parameters, including temperature, pressure, pH, reaction time, vacuum, and agitation speed, and report deviations to the supervisor.
6. GMP Compliance: Ensure compliance with cGMP, safety requirements, SOPs, and applicable regulatory guidelines throughout manufacturing operations.
7. Material Management: Verify raw materials, intermediates, solvents, and other process materials before use, ensuring proper identification, status labeling, and traceability.
8. Housekeeping and Safety: Maintain cleanliness and housekeeping in the production area and follow safety procedures for handling chemicals, solvents, and hazardous materials.
9. Yield and Reconciliation: Record batch yields, material consumption, solvent recovery, and material reconciliation as per approved procedures.
10. Coordination with Other Departments: Coordinate with Quality Control (QC), Quality Assurance (QA), Engineering, Warehouse, and EHS departments for smooth production operations.

Preferred candidate profile

• Qualification: B.Sc. Chemistry, M.Sc. Chemistry, B.Pharm, or M.Pharm, as per company requirements.
• Experience: 15 years of experience in API production or pharmaceutical chemical manufacturing; experience requirements may vary by designation.