1. Ensuring implementation of approved procedures.
2. To monitor and ensure that the current updated Documents and formats are in use.
3. Monitoring of Stability programmes for FR&D projects
4. Involving in Customer, regulatory audits.
5. Review and approve of all SOPs, Process validation protocols, BOMs, Master
formula cards Preparation Batch production and control Records (BPCR), Master
Specifications, Technology Transfer documents and Stability data review.
6. Review of site master file and ensure that is available
7. Coordinating with corporate affairs for approvals of projects licence.
(Test Licence ,Manufacturing licence)
8. Handling Change controls, Deviations, Planned deviations,...