Quality Assurance Manager (OSD Facility)

Immacule Lifesciences · Bangalore, India

Key Responsibilities

• Lead overall Quality Assurance and Quality Management System (QMS) activities in compliance with cGMP and regulatory requirements.
• Review and approve SOPs, BMR/BPR, specifications, validation/qualification documents, SMF, VMP and other quality documents.
• Manage OOS/OOT, deviations, CAPA, change controls, complaints, recalls and investigations.
• Ensure effective implementation of IPQA, data integrity, quality risk management, self-inspections and audit compliance.
• Approve/review batch release, raw materials, packaging materials, intermediates and finished products.
• Ensure timely execution of process/cleaning/equipment validation, calibration, preventive maintenance and stability studies.
• Lead regulatory, customer and GMP audits, including inspection readiness and timely closure of observations.
• Review and approve Quality/Technical Agreements and monitor contract manufacturers, suppliers and external laboratories.
• Ensure compliance with pharmacopoeial, regulatory and statutory changes and their effective implementation.
• Oversee new product introduction and technology transfer from the Quality perspective.
• Conduct Quality Review Meetings and ensure timely closure of QMS activities.
• Drive continuous improvement and develop a strong quality culture across the organization.
• Lead and develop the QA team through manpower planning, work allocation, KRA setting and performance management.
• Ensure adequate manpower, budget and resources for the QA function.
• Coordinate cross-functionally with Manufacturing, QC, Engineering, Warehouse and other departments to maintain continuous GMP compliance and audit readiness.

Desired Profile

• 12–16 years of relevant experience in Pharmaceutical Quality Assurance, preferably in a regulated/USFDA environment.
• Strong hands-on experience in QMS, audits, investigations, CAPA, deviations, OOS/OOT, validation and regulatory compliance.
• Experience: 12–16 Years
• Qualification: B. Pharma / M. Pharma