Manager – Quality Assurance (OSD)

Acme Formulation; Solan; On-site; INR 1,200,000 - 2,600,000; Full time

Job summary

Acme Formulation in Solan, Himachal Pradesh, is seeking a Lead for Quality Management and IPQA to drive cGMP compliance across OSD manufacturing, granulation, coating, and packaging operations.

The role oversees qualification, validation, deviations, change controls, audits, and product releases, ensures data integrity, and promotes continuous improvement through training and QRM initiatives.

Candidates should have pharma QA experience and strong regulatory exposure in USFDA-compliant facilities.

Qualifications

• B.Pharm / M.Pharm / M.Sc. in a relevant pharmaceutical discipline.
• Relevant experience in Quality Assurance within pharmaceutical OSD manufacturing.
• Strong exposure to USFDA-regulated facilities, cGMP, QMS, IPQA, qualification, validation, audits, and regulatory compliance.

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.

Skills

Quality Management

Process Compliance

IPQA oversight

Education

B.Pharm / M.Pharm / M.Sc.

Tools

eQMS

Job description

• 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.
• Strong exposure to USFDA-regulated facilities, cGMP, QMS, IPQA, qualification, validation, audits, and regulatory compliance.