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QA Compliance Specialist

Expired Job

Novartis Pharmaceuticals Morris Plains , NJ 07950

Posted 4 months ago

Job Description:

PURPOSE

Manage and facilitate the internal Escalation process including involvement with the Complaint, Recall, Clinical Withdrawal and BPDR process. Coordinate escalation records within TrackWise.

MAJOR RESPONSIBILITES

  • 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

Employment Type

Regular


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QA Compliance Specialist

Expired Job

Novartis Pharmaceuticals