Production & Compliance Manager
Symbiotec Pharmalab Pvt. Ltd.Indore, Republic Of India, IN22 days ago
Job descriptionEnsure GMP compliance , and adherence to regulatory and safety guidelines (USFDA, EDQM, TGA, WHO). Review and approve Batch Manufacturing Records (BMRs) , SOPs , Deviation Reports , and Change Controls related to upstream activities. Prepare and support regulatory audits , customer audits , and internal inspections . Lead and develop a team of shift engineers, supervisors, and operators . Schedule manpower, oversee training and ensure adherence to SOPs and safety practices . Foster a culture of accountability , teamwork , and continuous improvement . Collaborate with R&D, Technology Transfer, and QA / QC teams to ensure smooth tech transfer and scale-up of new products. Drive process optimization to improve yield, reduce cycle time , and minimize solvent loss . Lead investigation of deviations, process failures , and implement corrective actions . Oversee the operation and maintenance of key upstream equipment : Reactors (GLR / SSR), condensers, scrubbers, distillation units, receivers , etc. Coordinate with the Engineering team for preventive maintenance and equipment validation . Monitor raw material consumption, solvent usage, and utility consumption. Drive cost-reduction initiatives without compromising quality or compliance. Deep understanding of chemical reaction engineering and process safety . Expertise in hazardous reaction handling , including exothermic and pressure reactions. Sound knowledge of GMP , cGMP , ICH , and regulatory requirements . Strong leadership, team management, and problem-solving abilities. Proficiency in production software (e.G., SAP, DCS, MES) is an added advantage. B.E. / B.Tech in Chemical Engineering or equivalent OR M.Sc. in Chemistry / Organic Chemistry / Industrial Chemistry
Key Responsibilities :
Production & Operations Management :
- Manage end-to-end upstream processes including chemical reactions , crystallization , solvent recovery , and work-up operations .
- Plan and execute daily production activities to meet output, quality, and yield targets.
- Monitor critical process parameters (CPPs) and ensure adherence to process design and safety.
Compliance & Documentation :
People & Resource Management :
Process & Quality Improvement :
Plant & Equipment Oversight :
Inventory & Cost Control :
Key Skills and Competencies :
Educational Qualifications :
Experience Required :
15+ years of progressive experience in API manufacturing , with significant expertise in upstream operations including reaction handling , crystallization , and phase separation .
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Production Manager • Indore, Republic Of India, IN