20 Oct
|
Enaltec
|
Mumbai
Role & responsibilities
Production Operations: Execute API manufacturing activities as per approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), and established manufacturing procedures.
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.
Batch Documentation: Complete BMRs, equipment logbooks, process records, and other production documents accurately and in compliance with Positive Manufacturing Practices (GMP).
Equipment Operation: Operate and monitor reactors like SSR,GLR, centrifuges, dryers, filters, condensers, and other production equipment as per approved procedures.
Process Monitoring: Monitor critical process parameters, including temperature, pressure, pH, reaction time, vacuum, and agitation speed, and report deviations to the supervisor.
GMP Compliance: Ensure compliance with cGMP, safety requirements, SOPs, and applicable regulatory guidelines throughout manufacturing operations.
Material Management: Verify raw materials, intermediates, solvents, and other process materials before use, ensuring proper identification, status labeling, and traceability.
Housekeeping and Safety: Maintain cleanliness and housekeeping in the production area and follow safety procedures for handling chemicals, solvents, and hazardous materials.
Yield and Reconciliation: Record batch yields, material consumption, solvent recovery, and material reconciliation as per approved procedures.
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