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.

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

schedule ,etc.
1. To approval COA of raw material, in-process, intermediate, packing material, finished

products etc.
1. To review and approve of Quality Risk Assessment.
1. To issue the quality systems related documents e.g batch production records, analytical

record, SOPs, logbooks, formats, specification, test protocols etc
1. 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
1. To review and approve laboratory incidents e.g out of specification (OOS), Incident, Event,

Out of Trend (OOT), CAPA etc
1. To prepare and review investigating of deviation, market complaint, CAPA, change control

etc.
1. 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.
1. To Review and approve Analytical Reports, calibration records and analyst qualification

reports (AQ) etc.
1. To Handling of non-conformity as per defined procedure.
1.



To Monitoring and ensuring the good laboratory practice (GLP) by laboratory personal

during the routine analysis and instrument operation ensure adherence to procedure.
1. To Monitoring and ensuring the valuable manufacturing practice (GMP) at manufacturing site.
2. To schedule and provide training on quality-related procedures and regulations.
3. To conduct internal audit, raw/packing material vendor audit, service provider audit as per

the schedule to ensure compliance.
1. To receive and store compiled/filled documents and update the respective register, wherever applicable.
2. To maintain quality documents and storage in a good condition.
1. To assign the batch for dispatch as per the customer requirement and plan the dispatch in

coordination with production, stores and quality control.
1. To monitor the review activity for the in-process, intermediate, raw material, packing

material, finished goods and water protocol along with the review of audit trail wherever applicable and lock the sequence.
1. To perform In-process Quality Assurance Rounds (IPQA) in Quality Control Lab.
1. To review schedules for instrument calibration, hold time study, stability study, etc.
2. To review the stability/ hold time study program and maintain the related documents.
3. To review the retention samples, record and maintain the related documents.
4. To Follow instruction given by Head of Department (HOD).

Preferred candidate profile

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