1. Authorization of requests for creation of item codes/SFG/FG codes and documents.
- 2. Review of compliance status in R & D location, including QA rounds.
- 3. Review of SOPs for continuous improvements & harmonization across R & D locations
- 4. Review & trending of QMS events including audit findings to present in Quality System review
- meeting
- 5. Assure system of easy archival & retrieval
- 6. Internal audit response, review and compliance.
- 7. Support to Stability chamber maintenance, Instrument and Equipment qualifications and Master Data Team.
- 1. Change Management: QA Assessment, Assigning the CC for SME Comments, Creation of
- Task for the Tracking of Activity and send for QA Approval and tracking of closure of change
- controls. Review and Approval of Tasks and Change controls & approval of Effectiveness.
- 2. Deviation Management: Assessment, approval and closure of deviations.
- CAPA Management: Assessment, approval, closure of CAPA & ensuring CAPA effectiveness