Deputy Manager Analytical Quality Assurance
Aarti Pharmalabs · Bharuch · onsite · Posted 72d ago
About a minute. You'll make an account on the way through.
About this role
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 good 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/filled documents and update the respective register, wherever applicable.
17.
To maintain quality documents and storage in a good condition.
18. To assign the batch for dispatch as per the customer requirement and plan the dispatch in
coordination with production, stores and quality control.
19. 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.
20.
To perform In-process Quality Assurance Rounds (IPQA) in Quality Control Lab.
21. To review schedules for instrument calibration, hold time study, stability study, etc.
22. To review the stability/ hold time study program and maintain the related documents.
23. To review the retention samples, record and maintain the related documents.
24.
To Follow instruction given by Head of Department (HOD).
Preferred candidate profile
Sourced from naukri
Skills
About Aarti Pharmalabs
Aarti Pharmalabs
Pharma
2.0k+
employees
Mumbai
India
₹6.6L PA avg
Avg at Aarti Pharmalabs
About
Aarti Pharmalabs Limited (APL) is a leading Indian manufacturer of Pharmaceuticals and Nutraceuticals with a global footprint. We deliver process chemistry expertise, with a scale-up engineering competence, regulatory support and long-term supply by maintaining quality and timely delivery to create a sustainable future.
Over the last two decades, APL serving global clients with top notch scientific knowledge, industry experts, state-of-the-art R&D and USFDA, EUGMP, EDQM, KFDA inspected manufacturing facilities. We manufacture Generic APIs, Intermediates and Xanthine derivatives. We offer CDMO services for small molecules drug substances (API/NCE/RSM/Intermediate) process development and manufacturing focusing on Ph-I/II/III, launch and commercial phase projects for Innovator Pharmaceutical and Biotech companies. We have been helping our clients to bring their molecules to market quickly and efficiently from clinical development through commercial stage manufacturing.
We have dedicated facilities to manufacture HPAPIs, Corticosteroids, Cytotoxic and Oncology products.
We are one of the preferred partner for Beverages and Nutraceuticals Industries for our flagship product ‘Caffeine’.
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Culture
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Career growth
2.1
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