MDI & DPI Manager

Job description

Role & responsibilities • Lead the establishment, commissioning, qualification, and commercialization of MDI (Metered Dose Inhaler) and DPI (Dry Powder Inhaler) production and packing lines. • Manage end-to-end manufacturing operations including production planning, execution, packing, and dispatch activities. • Ensure compliance with cGMP, USFDA, MHRA, EU-GMP, WHO-GMP, and other regulatory requirements. • Develop, implement, and maintain Quality Management Systems (QMS) including Deviations, CAPA, Change Control, Risk Assessment, SOPs, Investigations, and Audit Compliance. • Drive technology transfer, process validation, equipment qualification (DQ/IQ/OQ/PQ), and cleaning validation activities. • Establish robust manufacturing and packing processes to achieve productivity, quality, and cost targets. • Lead and manage cross-functional teams comprising Production, Packing, Engineering, Warehouse, and Quality departments. • Ensure effective manpower planning, team development, performance management, and succession planning. • Monitor and improve key performance indicators (KPIs) such as OEE, productivity, yield, rejection, and compliance metrics. • Lead regulatory, customer, and internal audits and ensure timely closure of observations. • Implement Lean Manufacturing, Operational Excellence, and Continuous Improvement initiatives. • Ensure adherence to EHS (Environment, Health & Safety) standards and promote a strong quality culture. • Manage budget planning, resource utilization, and cost optimization projects. • Provide strategic leadership for capacity expansion, new product introductions, and operational excellence programs. Preferred candidate profile • B.Pharm/M.Pharm/B.Tech/M.Sc. with 8-15 years of experience in MDI & DPI production and packing operations in a regulated pharma environment. • Proven expertise in establishing and commissioning MDI & DPI manufacturing and packing lines, including qualification and validation activities. • Strong knowledge of QMS, cGMP, regulatory compliance, technology transfer, audit management, CAPA, and change control systems. • Demonstrated leadership skills with experience in team management, operational excellence, productivity improvement, and cross-functional coordination.