Track and monitor site performance for improving quality index.
Identify the key challenges and improvement areas. Discussion with site on action plan for improvement.
Review of batch rejection, market complaint, FAR/Recalls, Invalidated OOS - Monthly tracking, review and collation of details and discussion with site Quality for action plan.
To support site for audit readiness through discussion, site visit and providing reference documents to enhance compliance.
To review audit compliance report.
Update on status of Regulatory inspection, CQA audit and upcoming inspection on monthly basis.
Qualification & Experience
Graduate / Post-Graduate in Pharmacy with 12+ Years of Experience in Pharma QC-QA.