Perform data aggregation and verification for existing open GMP / GCP / CSV CAPAs (both from internal Audits and Regulatory Inspections) and deviations, and also perform analysis of the CAPAs
Analysis shall involve aggregation and prioritization of the existing open records based on parameters like the criticality of the findings, regulatory impact, ageing, systemic or local issues, repeat observations, etc.
Perform trend analysis and suggest pre-emptive actions wherever applicable.
Perform data entry in TrackWise, follow up with respective stakeholders for timely and effective closure of assigned CAPAs / findings, and deviations, by performing all the required processes including the Root Cause Analysis (RCA), writing Corrective and Preventive actions; tracking and monitoring CAPAs with the assigned stakeholders, and ensuring an effectiveness check, where applicable.
Responsible for TrackWise entries of the mock inspection report findings.
|Experience||4 - 9 Years|
|Salary||4 Lac 50 Thousand To 8 Lac 50 Thousand P.A.|
|Industry||Pharma / R&D / Biotech|
|Key Skills||QA Specialist GMP GCP Regulatory Inspection|
|Contact Person||Mr. Abhishek|
|Address||A/59,Shop No-1,Sec-21,Turbhe,Navi -Mumbai,400705|