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