Key Roles & Responsibilities
• Lead and manage the overall Quality Management System (QMS), ensuring effective implementation, monitoring, and continual improvement in compliance with cGMP and regulatory requirements.
• Lead and oversee IPQA activities across OSD manufacturing, granulation, compression, coating, capsule filling, and packing operations to ensure process compliance and product quality.
• Lead and manage qualification and validation activities, including equipment, utilities, process validation, cleaning validation, and computer system validation, wherever applicable.
• Review and approve site master documents, including SMF, VMP, SOPs, BMR/BPR, specifications, analytical procedures, artwork, and validation/qualification protocols and reports.
• Review and approve deviations, change controls, OOS, OOT, market complaints, product recalls, and CAPA through eQMS.
• Ensure effective batch documentation review and approval/rejection of raw materials, packaging materials, intermediates, bulk, and finished products, as applicable.
• Ensure appropriate authorization for finished product release and compliance with regulatory and quality requirements.
• Drive implementation of Quality Risk Management (QRM), data integrity, and continuous improvement initiatives.
• Ensure effective investigation, root cause analysis, CAPA implementation, and effectiveness verification for quality-related incidents.




• Lead internal audits, external audits, customer audits, and regulatory inspections, ensuring continuous inspection readiness.
• Review, approve, and monitor contract manufacturers, suppliers, external laboratories, and associated Quality/Technical Agreements.
• Ensure timely execution and monitoring of product stability studies and technology transfer activities.
• Ensure compliance with applicable regulatory updates, pharmacopoeial requirements, and revised GMP guidelines.
• Coordinate with Manufacturing, QC, Engineering, Warehouse, and other functions to strengthen site-wide quality compliance.
• Conduct periodic Quality Review Meetings and monitor QMS performance and timely closure of quality activities.
• Ensure effective implementation of departmental training and competency development programs.
• Manage departmental manpower, budget, KRAs, performance assessment, and resource allocation.
• Drive the organization's Quality Policy and promote a strong quality culture across the manufacturing facility. Educational Qualification & Experience
• B.
Pharm / M.
Pharm / M.
Sc. in a relevant pharmaceutical discipline.
• Relevant experience in Quality Assurance within pharmaceutical OSD manufacturing.
• Solid exposure to USFDA-regulated facilities, cGMP, QMS, IPQA, qualification, validation, audits, and regulatory compliance.

📌 Manager – Quality Assurance (Nalagarh)
🏢 Acme Formulation
📍 Nalagarh