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 Valuable 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.

📌 Production Chemist / Production Officer - API Pharmaceutical (Mumbai)
🏢 Enaltec
📍 Mumbai