DS-DQA - Sr. Executive / Assistant Manager

Hyderabad ₹5-10 LPA Posted 20 May 2025

FULL TIME

Risk Assessment

Change Control

Bpr

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.