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APQR Reviewer

2.00 to 5.00 Years   Mumbai City   14 Sep, 2019
BVR People Consulting
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

Compile annual product quality reviews (APQRs) per applicable SOPs. Collect, analyse & summarize product review data correctly & completely Assist Company in the preparation & support activities related to APQRs for regulatory& customer audits, as required Profile Description: Perform Annual Product Quality Reviews (APQRs)as assigned. This includes the following at minimum, as per SOP :

  1. Manufacturing Process Overview
  2. Batches Released / Rejected
  3. APIs, Excipients
  4. Changes
  5. Test Method and Specification
  6. Manufacturing / Process Validation, Equipment and Utilities Qualification
  7. Sterility Validation / Qualification (If applicable)
  8. Packaging Component Deviations/Changes
  9. Compendial Review
  10. Deviations
  11. Critical In-Process Attributes
  12. Analytical Test Results
  13. Recalls and Field Alerts, Returns
  14. Retention Samples Review
  15. Technical Agreements (as appropriate)
  16. Marketing Authorizations Variations and Post Market Commitments (as appropriate)
  17. Complaints
  18. Stability
  19. Conclusion and Product Rating
  20. Concerns, Recommendations and Issues for Follow-Up
  21. Perform complete & correct transactions of the data as per SOP / WIs.
  22. Summarize & trend analytical data from LIMS or other acceptable systems.
  23. Ensure that the complete APQR is submitted for review and accepted by the ARPL COE Reviewer and Project Leader QA Product Review/Manager, QA Product Review.
  24. Co-ordinate with Project Leader(s) QA Product Review / Manager for completion of the projects.
  25. Compile the APQRs within required timelines to ensure that there is adequate time for approvals.
  26. Responses to Project Leaders queries for APQR summary reports as required.
  27. Assist in preparation, review & revision of Standard Operating Procedures (SOPs) as required.
  28. Ensure that all work is performed in compliance with GMP, SOPs, regulatory requirements & established safety standards.
  29. Work both independently & as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business & quality standards.
, Education:UG -B.Sc - Any Specialization, B.Pharma - PharmacyPG - M.Pharma - Pharmacy, MS/M.Sc(Science) - Any Specialization

Keyskills :
productquality customeraudits ts qualityreviews qualityassurance processvalidation manufacturingprocess ummaryrep

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