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Senior Associate- EQA

3 - 7 years

0 Lacs

west bengal

Posted:1 week ago| Platform: Shine logo

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Skills Required

vendor audit api pkg ctl csp qms master control supplier qualification corporate internal audit service provider qualification ksm exp sterile manufacturing facility technical agreement vendor audits regulatory inspection compliance capa tracking qta tracking qms in trackwise regulatory capa

Work Mode

On-site

Job Type

Full Time

Job Description

You will be responsible for supplier qualification, vendor audit, corporate internal audit, and service provider qualification. This includes maintaining documents for vendors related to API, KSM, PKG, EXP, CTL, and CSP. Your main tasks will involve performing vendor qualification for suppliers and service providers at all PAR India sites, including sterile manufacturing facilities. You will need to maintain the overall qualification status and monitor re-evaluation on a scheduled basis. Additionally, you will execute, review, and follow-up on technical agreements with suppliers and service providers, conduct vendor audits as required, and ensure vendors comply with regulatory inspections and quality standards. You will support the lead auditor with vendor qualification, CAPA tracking, and QTA tracking. Handling QMS in Trackwise and documentation in Master control will be part of your responsibilities. Monitoring the implementation of regulatory CAPA in a timely manner across all sites is also key. To be successful in this role, you should have a minimum Bachelor's degree, hands-on experience in sterile vendor qualification or analytics in a GMP environment, and experience in QA, RA, or qualification. Your commitment to diversity, equity, and inclusion is also highly valued in this position.,

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