AGM / DGM - API Production (Gujarat)

Key Responsibilities
- Lead end-to-end API production operations for multiple products in compliance with cGMP and regulatory requirements.
- Ensure achievement of production targets with optimum utilization of manpower, equipment, utilities, and resources.
- Drive process improvements for productivity enhancement, cycle time reduction, yield improvement, and cost optimization.
- Handle technology transfer, scale-up, validation batches, and commercialization of recent products.
- Ensure compliance with QMS systems including Deviation, CAPA, Change Control, OOS/OOT, SOPs, and documentation practices.
- Support and face regulatory audits such as USFDA, MHRA, TGA, WHO, customer audits, and internal audits.
- Drive process safety initiatives including HAZOP, PHA, risk assessments, incident investigations, and EHS compliance.
- Coordinate with cross-functional teams including QA, QC, Warehouse, Engineering, SCM, and R&D; for smooth plant operations.
- Participate in plant expansion, commissioning, equipment qualification, automation, and continuous improvement projects.
- Monitor production costs, utility consumption, inventory, and implement cost-saving initiatives.
- Lead and mentor production teams to build a high-performance and compliance-driven culture. Desired Candidate Profile
- B.E./B.Tech in Chemical Engineering OR M.Sc. Chemistry / Organic Chemistry
- 20 + years of experience in API / Bulk Drug manufacturing operations
- Strong exposure to regulated plants and multi-product API manufacturing
- Experience in technology transfer, scale-up, process optimization, and production planning
- Hands-on exposure to regulatory audits and compliance systems
- Strong leadership, problem-solving, and team management skills
- Exposure to SAP/ERP systems and automation/PLC systems will be preferred Apply on Kit Job: kitjob.in/job/4mbzqr