Job Description
Key Responsibilities
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- Lead overall Quality Assurance and Quality Management System (QMS) activities in compliance with cGMP and regulatory requirements.n
- Review and approve SOPs, BMR/BPR, specifications, validation/qualification documents, SMF, VMP and other quality documents.n
- Manage OOS/OOT, deviations, CAPA, change controls, complaints, recalls and investigations.n
- Ensure effective implementation of IPQA, data integrity, quality risk management, self-inspections and audit compliance.n
- Approve/review batch release, raw materials, packaging materials, intermediates and finished products.n
- Ensure timely execution of process/cleaning/equipment validation, calibration, preventive maintenance and stability studies.n
- Lead regulatory, customer and GMP audits, including inspection readiness and timely closure of observations.n
- Review and approve Quality/Technical Agreements and monitor contract manufacturers, suppliers and external laboratories.n
- Ensure compliance with pharmacopoeial,



regulatory and statutory changes and their effective implementation.n
- Oversee current product introduction and technology transfer from the Quality perspective.n
- Conduct Quality Review Meetings and ensure timely closure of QMS activities.n
- Drive continuous improvement and develop a strong quality culture across the organization.n
- Lead and develop the QA team through manpower planning, work allocation, KRA setting and performance management.n
- Ensure adequate manpower, budget and resources for the QA function.n
- Coordinate cross-functionally with Manufacturing, QC, Engineering, Warehouse and other departments to maintain continuous GMP compliance and audit readiness.n

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n Desired Profile
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- 12–16 years of relevant experience in Pharmaceutical Quality Assurance, preferably in a regulated/USFDA environment.n
- Strong hands-on experience in QMS, audits, investigations, CAPA, deviations, OOS/OOT, validation and regulatory co

📌 Quality Assurance Manager (Baddi)
🏢 Immacule Lifesciences
📍 Baddi