Job Overview
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Date PostedAugust 20, 2023
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Location (State / UT)
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Expiration dateAugust 14, 2024
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Experience7 Years, 12 Years
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GenderAny
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Desired QualificationMaster’s Degree, Bachelor Degree
Job Description
Role & Responsibility:
- To ensure cGMP compliance at the site.
- Responsible for Vendor Qualification and Management at Acme Group and companies.
- Day-to-day coordination with QA-representative w.r.t. Vendor Qualification/Re-Qualification and Management status at each plant of Acme group.
- To review vendor documents for Vendor Qualification.
- To perform the Vendor audit and its compliance for RM/PM.
- To prepare Vendor Audit Reports and confirm compliance.
- To Review and Approve the Approved Vendor List of RM/PM.
- To Review/Approve Annual vendor audit Planner/Scheduler.
- To receive the pre-purchase samples through Purchase Team and send them to QC/ARD for further assessment.
- To review the Pre-purchase analyzed report and take the necessary action as applicable.
- To participate in investigation/QRM related to the vendor of RM/PM (wherever required).
- Follow-up with the vendor regarding CAPA (wherever applicable).
- To review and approve the assessment report of Nitrosamine/Elemental and Genotoxic Impurities in Finished Product.
- To review and approve the assessment report of Ethylene and Di-ethylene contamination risk in Drug Products.
- To review and approve the Risk Assessment.
Desired Candidate Profile:
Qualification: B.Pharma, M.Pharma
Experience: 7-12 Years
Salary: 08-12 L CTC/PA