GCP GVP Auditor

-Manage QA deliverables. -Protocol review of different dosage and different guidelines -Departmental SOP review -Review regulatory and sponsor query -Auditing pharmacovigilance activities -Preparing DCGI Application for BABE facility approval /renewal. -Performing System /vendor audit

GCP and GPV Auditor 1.Performing In-house Bio studies Audit in adherence of Regulatory guidance,SOP and Study Protocol2.Performing System Audit and Facility Audit3.Responding Sponsor as well as Regulatory Queries4.Performing trend analysis within System and identify critical incident and escalate to the Management and follow up to the resolves.5.Retrospective clinical raw data review6.Review of Standard operation procedure of 7.Different Departments in view of Regulatory requirements and current system.8.Review Study Protocol, ICF and CRF in adherence of Regulatory guidelines.9.Final Study Report review as per ICH E3 requirements10.Performing vendor Audit as per Company contract and in adherence of Agreement and basic Regulatory requirements.11. Review Pk stat raw data ,it's report and CDISC output.12.Delegate and Managing QA deliverables as per study timeline.13. Assist sponsor in facility round and to the inspector in regulatory inspection.14. Auditing of Pharmacovigilance department .

GCP Auditor

Clinical trial protocol ,ICF review. Inprocess audit activity.CRF designing and review.Site selection, site monitoring.Raw data review.Clinical report review.Ensure ICH GCP compliance.Clinical investigational product supply to clinical site.Tanning to study staff.System audit, vendor audit.

Clinical Quality Assurance