GM

Job Description : GM - API Projects (Greenfield) KENYA Domain: API - Active Pharmaceutical Ingredient Qualification: B.E. / B.Tech (Chemical / Mechanical) / M.Tech / B.Pharm + MBA Projects We are looking for a seasoned professional with proven expertise in end-to-end execution of Greenfield API Projects from Concept to Commissioning. Roles & Responsibilities: 1. Project Management (Concept to Commissioning) Lead entire lifecycle of Greenfield API project - Feasibility, Basic & Detail Design, Engineering, Procurement, Construction, Commissioning, Qualification & Validation. Preparation and monitoring of Project Schedule, Budget (CAPEX), Resource planning and Risk mitigation. Co-ordination with Design consultants, PMC, Vendors and internal cross-functional teams. 2. Engineering & Procurement Review of P&IDs, Equipment Layouts, Utility Design, Process Flow Diagrams. Selection, evaluation and finalization of equipment for Reactors, ANFD, Centrifuges, Dryers, Clean Room, HVAC, Water Systems, Solvent Recovery etc. Vendor development, Techno-commercial evaluation, Negotiation and Procurement. 3. Construction & Execution On-site execution leadership, ensuring project delivery on time and within cost. Leading large cross-functional teams including Engineering, QA, QC, Production, EHS, Maintenance. 4. Compliance & Quality Ensuring 100% compliance with cGMP, EHS, Statutory norms and Safety (HAZOP, HAZID). Strong exposure and readiness for USFDA, EU-GMP, WHO-GMP regulatory requirements for API facilities. Handling of QMS, Change Control, Deviation, Documentation for regulatory audits. Liaison with Government bodies, Pollution Control Board, Factory Inspectorate etc. Desired Candidate Profile: Must have 18+ years of experience in API industry with at least 2-3 Greenfield / Brownfield project executions. Proven track record in managing budgets, large teams, and timely delivery. Excellent knowledge of regulatory and statutory compliance for API manufacturing.

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