Assistant General Manager, Manufacturing Injectables
Core
Oversee production planning, execution, and quality compliance for injectable manufacturing operations to meet business demands and GXP standards.
Role type
Assistant General Manager, Manufacturing
Builds
Injectable pharmaceutical products
Domain
Healthcare / Pharmaceutical Manufacturing
Required skills
Production planning, GXP compliance, SOP development, Cross-functional team leadership, Troubleshooting, Process improvement, Validation management, Quality system documentation, New product introduction, Training delivery
Preferred skills
None stated
Technologies
None stated
Responsibilities
Develop and introduce systems to meet production targets within GXP standards; Prepare monthly production plans based on material availability; Allocate daily work to supervisors and workmen; Coordinate with Warehouse, QC, and QA for material release; Implement process efficiency improvements; Manage troubleshooting and corrective actions; Perform gap analysis on Batch Manufacturing/Packing Records and SOPs; Train workforce on productivity and operational efficiency; Execute new product introduction and technology transfer; Review SOPs and ensure error-free documentation submission; Coordinate media fill validation and equipment qualification; Review annual validation, preventive maintenance, and calibration plans; Manage QMS documents (change control, deviations, CAPA, Risk Assessments); Conduct self-inspections for facility and system improvement; Ensure regulatory compliance for investigations.
