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▷ Urgent Search : Deputy General Manager (DGM) / Assistant General Manager (AGM) – Upstream Productio
Symbiotec Pharmalab Pvt. Ltd.India5 hours 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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