1. Responsible for Issuance, distribution and archiving of SOPs, formats, protocols, reports, batch records, cleaning records and other master documents.
2. Monitoring of Analytical Department, Quality control and Microbiology activities are in line with SOP.
3. Responsible for review of Equipment/Instrument qualification documents.
4. Responsible for reviewing In-process and Intermediates and finished products raw data.
5. Responsible for logging, reviewing and approval of Lab occurrences.
6. Responsible for logging and review of Change Controls, Deviations, CAPA, OOT and OOS.
7. Responsible for review of Analytical method validations and Stability protocols and reports along with supporting data.
8. Responsible for conducting internal audits.
9. Responsible for Co-ordinating Training activities.
10.
Responsible for review of Analytical method transfer protocols and reports.
11. Responsible for review and approval of Certification of standards.
12. Responsible for reviewing scleaning method validation protocols and reports.
13. Responsible for soft copy review of analytical data and its audit trails.
14. Responsible for review of Water and Environmental monitoring trend data.
15. Responsible for review of Specifications and test procedure.
16. Responsible for approval of analytical raw data work book.
17. Responsible for preparation and review of Validation Schedules and reports
Responsible for review protocol and reports of various activities in Quality Control, Analytical Development & Microbiology departments