Manage and facilitate the internal Escalation process including involvement with the Complaint, Recall, Clinical Withdrawal and BPDR process. Coordinate escalation records within TrackWise.
Coordinator of Escalation events relating to deviations, complaints and recall; schedule meetings and collaborate with Multi-functional team for escalation meeting presentations
Manage and complete Global escalation forms beyond level 1; Coordination with NVS colleagues within CGT to support level 1 escalation and with ex-CGT (Global, CPO, etc.) to support level 2 and higher escalations.
Perform complaint investigations and facilitate escalation as needed
Authoring SOPs and/or Work Instruction relating to the escalation process and local recall process
Manage, monitor and coordinate records in TrackWise System relating to escalation and complaints modules
Perform final QA review/approval of GMP documents in ESOPs
Contributing and providing report for APQRs for Complaints, BPDR, Recall and FARs
Manage KPI metrics and slide presentation for escalations, Complaints, BPDR, Recalls and FARs to Site Quality Council and Quarterly Review Boards
Function as Complaint liaison for CGT between Customer Complaint group, CPO QA and Country CPO