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Immacule Lifesciences
Quality Assurance Manager (OSD Facility)Immacule Lifesciences • Tiruppur, IN
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Quality Assurance Manager (OSD Facility)

Quality Assurance Manager (OSD Facility)

Immacule Lifesciences • Tiruppur, IN
23 days ago
Job description

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

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Quality Assurance Manager (OSD Facility) • Tiruppur, IN

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