- 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.