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Quality Assurance Head

Job Description - Quality Assurance Head

Key Responsibilities

Regulatory Compliance
  • Ensure site compliance with MHRA, EU GMP, WHO, and other international regulatory requirements.
  • Lead regulatory inspections (MHRA, USFDA, EU, etc.) and customer audits; ensure timely CAPA implementation.
  • Maintain and ensure readiness of quality systems for inspections.
Quality Systems Oversight
  • Manage and continuously improve QMS (Deviation, Change Control, CAPA, OOS/OOT, Market Complaints, Product Recall).
  • Ensure timely review and approval of documents like SOPs, protocols, master BMRs/BPRs, and validation documents.
  • Conduct periodic Quality Risk Management (QRM) activities and internal audits.
Documentation & Data Integrity
  • Ensure data integrity compliance across systems (manual & electronic); drive ALCOA+ principles.
  • Monitor and review batch records, laboratory data, and QA documentation for accuracy and completeness.
Team Management
  • Lead and mentor QA team (IPQA, documentation, QMS, and validation units).
  • Drive training programs for quality awareness, cGMP, and regulatory updates.
Product Release
  • Final review and approval of batch manufacturing and analytical records for product release.
  • Coordinate with QC and production for timely batch disposition.
Continual Improvement
  • Drive site -level quality improvement initiatives.
  • Collaborate with cross -functional teams for process optimization and quality enhancement.



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