QA/QC_AM/DM
Job description
Prepare/review audit planner as per SOP in TrackWise as per requirement and planning of audits as per prepared schedule for existing/New proposed contract manufacturing sites and Depots. Perform audits of Contract manufacturing sites and Depots. Escalate the audit compliance related issues like inadequate CAPA, overdue CAPA, disagreement of the location for compliance etc. to the reporting manager for further action. Ensure Lead time for releases at LL Sites by analyzing route cause for increased lead time to give release on time. Ensure the OTIF at LL/P2P sites against SLA Review analysis lead-time of LL sites for RM/PM/FP through QC Register and Preparation of data of lead time/OTIF of LL/P2P sites Analysis witness for results verification/OOS/OOT/market complaint samples and OOS/OOT of stability samples at sites/PTL also
Skills Required
Key Skills
- SOP
- CAPA
- OTIF
- OOS
- OOT
- PTL
- LL/P2P
- SLA
Other Information
