Role & responsibilities

To review the Validation Master Plan, Site Master File, Drug Master File, Annual Product

Quality Review, Plant Layout and other documents related to QA.

2. To review quality systems related documents e.g SOPs , vendor list, audit plan, audit

schedule ,etc.

3. To approval COA of raw material, in-process, intermediate, packing material, finished

products etc.

4.

To review and approve of Quality Risk Assessment.

5. To issue the quality systems related documents e.g batch production records, analytical

record, SOPs, logbooks, formats, specification, test protocols etc

6. To review, assess, and approve Quality Management System (QMS) documentation,

including Change Control, Deviation, Out-of-Specification (OOS), Out-of-Trend (OOT),

Market Complaint, Incident, Event, Returned Goods, and CAPA records

7. To review and approve laboratory incidents e.g out of specification (OOS), Incident, Event,

Out of Trend (OOT), CAPA etc

8. To prepare and review investigating of deviation, market complaint, CAPA, change control

etc.

9.



To review and approve of quality systems related documents e.g. Batch production records,

Process validation Protocol, qualification protocol & reports, Continuous Process

Verification Report, Annual Product Quality Review etc.

10. To Review and approve Analytical Reports, calibration records and analyst qualification

reports (AQ) etc.

11.

To Handling of non-conformity as per defined procedure.

12. To Monitoring and ensuring the valuable laboratory practice (GLP) by laboratory personal

during the routine analysis and instrument operation ensure adherence to procedure.

13. To Monitoring and ensuring the good manufacturing practice (GMP) at manufacturing site.

14. To schedule and provide training on quality-related procedures and regulations.

15. To conduct internal audit, raw/packing material vendor audit, service provider audit as per

the schedule to ensure compliance.

16. To receive and store compiled/fill

📌 Deputy Manager Analytical Quality Assurance (Bharuch)
🏢 Aarti Pharmalabs
📍 Bharuch