Corporate Quality Assurance

3 weeks ago

Mumbai, India Ajanta Pharma Ltd Full time

Executive- Corporate Quality Assurance

Key Responsibilities:

1. Vendor & Supplier Qualification & Documentation:

  • Review and maintain documentation such as:
  • Vendor Assessment Questionnaires (for Raw Material & Packing Material)
  • Supplier Assessment Questionnaires (for Raw Material & Packing Material)
  • Inspection Reports
  • Vendor/Supplier Approval & Disqualification Forms
  • Coordinate with site and head office personnel to gather required vendor/supplier documents.
  • Organize and perform desk audits for APIs, key starting materials, and packing materials.

2. Inspections & Audits:

  • Conduct vendor inspections for:
  • Starting materials
  • Packing materials
  • Contract testing laboratories
  • Contract manufacturing sites
  • Other service providers
  • Perform supplier inspections for raw and packing materials.
  • Prepare and maintain audit reports and follow up on CAPA implementation.

3. Material & Quality Communication:

  • Notify Commercial and applicable site departments of any material rejections.
  • Liaise with internal stakeholders regarding sourcing, documentation, and inspection outcomes.

4. Documentation & System Management:

  • Maintain proper control and lifecycle management of quality documents including issuance, retrieval, archival, and destruction.
  • Manage records of vendor complaints across all sites and ensure CAPA monitoring and closure.
  • Prepare and maintain internal Corporate QA documents.
  • Use Document Control System (DCS) software for document issuance, retrieval, and obsolescence.
  • Manage Master Product Number (MPN) creation, extension to other locations, and resolve source-related issues in SAP.

Qualifications and Experience:

  • Bachelor's/Master's degree in Pharmacy, Chemistry, or related science discipline.
  • 8–10 years of experience in Quality Assurance within the pharmaceutical industry.
  • Experience in vendor/supplier qualification, audits, and regulatory compliance.

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