Ensure proper investigation tools have been used to identify the root cause/probable causes.
- Ensure correct CAPA is provided by the CMO as per the root cause that was arrived from the investigation.
- Investigator in Trackwise system & route it to the QA
Desired Candidate Profile : Keyskills :qa root cause investigation sterile injectable CAPA Trackwise system USFDA EU Batch Release Operation Quality Lead KPI Metrics Change Control LIRs Deviation Quality Assurance
Desired Candidate Profile : Experience in USFDA & MHRA Audit.Exp in Sterile & Injectable Product.
Ensure that there are no overdue investigations in TrackWise.
Act as investigator in Trackwise system & route it to the Operational Quality Lead/respective QRM's for approval & disposition.