Senior Quality Assurance Manager

4 days ago

Rajahmundry, Andhra Pradesh, India beBeeQuality Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Key Responsibilities:
  • Develop, implement, maintain, and improve quality assurance processes and GMP systems.
  • Coordinate vendor qualification activities, internal audits, compliance audits, Qualified Person audits, and Regulatory Inspections.
  • Manage close-out for all audits and inspections.
  • Establish a robust Quality Management System (QMS) to manage change management, deviation management, incident handling, complaint handling, and CAPA management.
  • Oversee investigations of non-conformances (deviations, complaints, etc.).
  • Handle Product Recall.
  • Create and maintain systems to implement ICH Q8 (Quality by Design), ICH Q9 (Quality Risk Management), and ICH Q10 (Pharmaceutical Quality System) requirements.

Additional Responsibilities:

  • Ensure cGMP requirements and quality standards are recognized, understood, and maintained across the organization.
  • Develop batch release and reject systems to ensure quality products are released to the market.
  • Work across disciplines to ensure the organization maintains a state of readiness for inspection by regulatory agencies.
  • Keep abreast of changes to quality regulations and guidelines, advising the management team on business implications.
  • Lead, manage, and ensure proper training for relevant change management programs throughout the organization.
  • Provide quality guidance to product development projects and programs.
  • Data Integrity Internal Audits, Training, and Review, with reporting to the management.
  • Evaluate validation activities (process/cleaning/method/equipment, etc.) according to approved protocols and requirements.
  • Maintain operational performance to meet regulatory authority, company SOPs, external, and internal customer requirements regarding quality, service, lead time, and cost.
  • Ensure departmental SOPs are developed, revised, and approved, ensuring regulatory compliance and being fit for purpose operationally and commercially.
  • Perform activities in accordance with GMP, company SOPs, and Health and Safety policies.
  • Implement self-inspection programs to meet EU GMP/PICS/TG/MHRA requirements.
  • Review, approve, and issue Batch Manufacturing Records/Batch Packaging Records.
  • Responsible for OOS/OOT.
  • Organize review meetings, document actions, and corrective measures implemented for cGMP requirements.
  • Monitor IPQA activities, review, and report.
  • Responsible as cGMP administrator, nominated by management.
  • Prepare, review, finalize, and submit documents to external customers and agencies as per regulatory requirements.
  • Adhere to Validation Master Plan and Validation Schedule.
  • Control Sample Management (Final Retention Samples) along with QC.
  • Stability Management along with QC team.
  • Quality Review Meetings and Management Review Meetings.
  • Documentation cell and Lifetime documents archival program.
  • Artwork Approval and Shade card maintenance.
  • Label management and Risk Management.
  • Shredding and maintenance.
  • Review of layouts along with Engineering Team.
  • Review of Pest Control management, Fire Extinguisher Annual documents along with EHS, HR, and Engineering Team.
  • Review and Finalization of water system validation documents along with Engineering department.
  • Transport validation, Review, and Finalization of protocol/Reports.
  • National and International Manufacturing Licensing activities along with Regulatory Affairs team for the Site and Archival.
  • Quality Agreements and Vendor Agreements adherence.
  • All dispatches of Finished Products as per country-specific approvals.

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