Deputy Manager - AQA

Adler Talent Solutions

Bharuch District

On-site

INR 600,000 - 900,000

Full time

8 days ago

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Job summary

Adler Talent Solutions in India seeks a QA professional to review and approve quality systems documents, COA, batch records, test protocols, and GMP compliance at the site.

You will conduct internal audits, manage CAPA, change control, deviation investigations, and ensure GLP/GMP adherence during routine analysis and production. The role involves preparing training on quality procedures and coordinating with production, quality control, and suppliers to ensure compliant operations.

Responsibilities

To review and approve Quality Management System (QMS) documentation, including Change Control, Deviation, OOS, OOT, Market Complaint, Incident, Event, Returned Goods, and CAPA records
To review, assess, and approve quality systems related documents e.g. batch production records, analytical records, SOPs, logbooks, formats, specifications, test protocols etc
To review and approve laboratory incidents e.g. OOS, Incident, Event, OOT, CAPA etc
To prepare and review investigations of deviation, market complaint, CAPA, change control etc.
To review and approve of quality systems related documents e.g. Batch production records, Process validation Protocols, qualification protocol & reports, CVR, APQR etc.
To Review and approve Analytical Reports, calibration records and analyst qualification reports (AQ)
To handle non-conformity as per defined procedure
To monitor good laboratory practice (GLP) by laboratory personnel during routine analysis and instrument operation
To monitor good manufacturing practice (GMP) at manufacturing site
To schedule and provide training on quality-related procedures and regulations
To conduct internal audits, vendor audits, and service provider audits as per schedule to ensure compliance
To receive and store compiled documents and update respective registers
To maintain quality documents and storage in good condition
To assign batches for dispatch as per customer requirements and coordinate with production, stores and quality control
To monitor review activity for in-process, raw material, packing material, finished goods and water protocols and review audit trails
To perform IPQA rounds in Quality Control Lab
To review schedules for instrument calibration, hold time study, stability study etc.
To review stability/hold time studies and maintain related documents
To review retention samples, records and related documents
To follow instructions from Head of Department (HOD)

Job description

To review the Validation Master Plan, Site Master File, Drug Master File, Annual Product Quality Review, Plant Layout and other documents related to QA.

To review qualitysystems related documents e.g SOPs , vendor list, audit plan, audit schedule ,etc.

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

To review and approve of Quality Risk Assessment.

To issue the qualitysystems related documents e.g batch production records, analytical record, SOPs, logbooks, formats, specification, test protocols etc

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

To review and approve laboratory incidents e.g out of specification (OOS), Incident, Event, Out of Trend (OOT), CAPA etc

To prepareand review investigating of deviation, market complaint, CAPA, change control etc.

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.

To Review and approve Analytical Reports, calibration records and analyst qualification reports (AQ) etc.

To Handling of non-conformity as per defined procedure.

To Monitoring and ensuring the good laboratory practice (GLP) by laboratory personal during the routine analysis and instrument operation ensure adherence to procedure.

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

Toschedule and provide training on quality-related procedures and regulations.

To conduct internal audit, raw/packing material vendor audit, service provider audit as per the schedule to ensure compliance.

To receive and store compiled/filled documents and update the respective register, wherever applicable.

To maintain quality documents and storage in a good condition.

To assign the batch for dispatch as per the customer requirement and plan the dispatch in coordination with production, stores and quality control.

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.