Posted 2 years ago

For a reputed Organization in API Manufacturing for Raichur (Karnataka) location

Experience required : 12+ Years

Experience in API Quality Assurance is must

Key responsibilities include:

  1. Approval of :
  • SOPs & Formats, Master BPRs, Specifications & Methods of Analysis (MOA), Vendor list, Annual Product quality review (APQR), Validation Master Plan, Site Layouts, P&I Diagrams, Vendor Documents, Validation Protocols & Reports, Quality Risk Assessments, Stability Study Reports, Analytical Method Validation Documents, Environmental Monitoring Summary Reports, Quality Agreements, Internal and External Calibration Schedules, Specimen Signatures, Quality comparison reports

 

  1. Investigation, recording findings, review and propose CAPA for the following
  • Customer complaints
  • Deviations
  • Out of specification (OOS) of Raw material, Intermediates and Finished Product
  • Incidents
  • Non-Conformances (NC)
  1. Responsible for all mail responses to
  • Regulatory authorities
  • Customers
  • Complaints
  • Contract manufacturers
  1. Review, acceptance, approval of Change Controls
  2. Conducting internal audits
  3. Participating in Regulatory Inspections
  4. To propose and implement corrective and preventive actions (CAPA) for observations made in internal and external audits
  5. Training to personnel on cGMP systems
  6. Responsible for Quality Review Meetings (QRM)
  7. Monitoring of GMP related activities in all departments
  8. Responsible for Vendor Audits
  9. Handling of Return Goods
  10. Handling of Recalls
  11. Ensure effective functioning of overall Quality Management System (QMS)
  12. Approve retest dates and extension of retest periods
  13. Authorize to stop production to ensure resolution of potential quality issues
  14. Authorized to Release or Reject of finished products
  15. Authorized to Approve or Reject the raw materials, intermediates and finished products.

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