Vendor Qualification & Management Executive Brillpharma

4.0 - 6.0 years

5 - 6 Lacs

mumbai suburban

Work from Office

Role & responsibilities Assist in vendor management activities including communication, follow-ups, and documentation. Review vendor/CMO quality system documents under guidance. Support in drafting, reviewing, and maintaining Quality/Technical Agreements with vendors/CMOs. Assist in conducting vendor performance evaluations and preparing reports. Help in risk assessments related to vendors, including supply chain mapping and excipient risk. Maintain records and databases for quality parameters, trending, and periodic assessments. Ensure compliance with GMP requirements, internal procedures, and regulatory updates. Support in reviews of assessments related to elemental impurities, excipient risks, and vendor quality. Adhere to Health & Safety (H&S) requirements and company policies. Perform other tasks as assigned by management. Preferred candidate profile Bachelors degree in Pharmacy, Life Sciences, or a related field. Basic knowledge of GMP guidelines and regulatory requirements. Good communication, coordination, and documentation skills. Proficiency in MS Office (Excel, Word, PowerPoint).

Posted 6 hours ago

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Senior Associate- EQA Endo International

3.0 - 7.0 years

0 Lacs

west bengal

On-site

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.,

Posted 1 week ago

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