DS-DQA - Sr. Executive / Assistant Manager

5 - 10 years

5 - 10 Lacs

Posted:1 month ago| Platform: Foundit logo

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Work Mode

On-site

Job Type

Full Time

Job Description

  • Responsible for Monitoring and support the Quality assurance of Vaccines under Development/Clinical/Technology Transfer
  • To ensure the compliance of product manufacturing against pharmacopoeia, WHO and other applicable regulatory guidance documents.
  • To monitor and ensure the shop floor compliance for manufacturing of clinical and Tech-Transfer batches.
  • To monitor and ensure the compliance of cell bank management.
  • Review of executed BPRs, testing reports, COA and EMP data for the development batches.
  • Handling and follow up for timely closure of Change Controls, Deviations, OOS, Risk assessment and OOLs.
  • Review & Approval of Protocols (PV,CV etc.), study reports, BPRs, MFRs SOPs and other documentation as needed.
  • Review of documents for Lot summary protocols. regulatory dossiers and other regulatory filings.

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