1. Strategic Procurement Management Develop and execute procurement strategies aligned with production and compliance needs. Plan sourcing of APIs, excipients, packaging materials, lab chemicals, and consumables. Ensure procurement planning supports uninterrupted manufacturing and new product launches. 2. Vendor Development and Management Identify and qualify new vendors, ensuring they meet regulatory and GMP standards. Conduct vendor audits (in coordination with QA/Regulatory teams). Establish long-term supply agreements with key suppliers to ensure continuity and quality. Monitor supplier performance (delivery timelines, quality, cost competitiveness). 3. Regulatory and Quality Compliance Ensure all procured materials have required documentation: CoA, MSDS, DMF, etc. Align purchase processes with FDA, WHO-GMP, and other regulatory body requirements. Maintain audit-ready documentation for all purchase transactions. Support cross-functional teams (QA/QC, RA) during internal/external audits. 4. Operational Purchasing Review and approve purchase requisitions and orders (within authority limits). Oversee the procurement of raw materials, intermediates, packaging materials, engineering spares, and third-party services. Coordinate with Production Planning, Inventory Control, and Finance teams for seamless operations. Implement JIT (Just-in-Time) principles wherever feasible. 5. Cost Control and Budgeting Monitor and optimize procurement costs without compromising quality. Analyze price trends and market fluctuations in APIs and bulk chemicals. Negotiate favorable payment terms, lead times, and logistics costs. Prepare and manage the purchase budget. 6. Team Leadership Lead and mentor a team of purchase executives, officers, and assistants. Build cross-functional synergy with QA, RA, Warehouse, and Production departments. Conduct training sessions to keep the team updated on compliance and procurement best practices. 7. ERP & Digital Tools Management Ensure accurate and timely procurement entries in ERP systems (e.g., SAP, Oracle, etc.). Use procurement analytics and dashboards for tracking key metrics like lead time, cost, and supplier performance. 8. Risk Management & Business Continuity Develop contingency plans for critical material shortages or supplier failures. Maintain a second source strategy for key raw materials and packaging components.
