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

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12–16 years of relevant experience in Pharmaceutical Quality Assurance, preferably in a regulated/USFDA setting.
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Strong hands-on experience in QMS, audits, investigations, CAPA, deviations, OOS/OOT, validation and regulatory compliance.
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Experience: 12–16 Years
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Qualification: B. Pharma / M. Pharma
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📌 Quality Assurance Manager Osd Facility Baddi
🏢 Immacule Lifesciences
📍 Baddi