Sanjay Khanke

WORK HISTORY

EDUCATION

SKILLS

ABOUT SANJAY KHANKE

I have 17 years of experience including 10 years of experience in Clinical Data Management and 7 years of experience in Quality management, Deviation handling, Leading Audit /Inspection & CAPA management, process & trainings. Key Skills – Quality issue handling, Leading Inspections & Audit preparations, Health authority CAPA management, Deviations & CAPA management, Root cause analysis & risk management, Risk management, Issue Trend analyses & risk-based approach, Project management, Stakeholder management, Strong communication skills, problem solving skills, tool development, Deviation management-Partner with business teams & Global QA stakeholders to ensure Quality Issues are identified, assessed, managed and resolved per established processes. Leads investigation of quality issues, drive root cause analysis (fishbone and/or 5 why techniques), risk assessments & define the CAPAs. Leading Audits and Inspections- Lead internal Audit & Health authority inspection preparation activities, including SME preparation, mock interviews, study level issues gap assessments, storyboard preparation Analyze the risks, propose the strategy for readiness. Provide lessons learned after each GCP inspection & internal audits.Identify and oversee implementation of Health Authority Inspection and internal audits CAPA.OKR, KPI, KQI and self-inspection finding presentations- Presenting the Operational Key Risk Indicator reports, key performance indicators, Key Quality indicators assessment findings to Leadership team.Authoring Data Privacy process and documents for Clinical Data Operations.Leads discussions with internal stakeholders and partners across and outside Clinical Data Operations (IT, Clinical development, Clinical operations, Patient safety & Clinical & medical operations) in support of quality deliverables and nonclinical projects Lead independently, coordinated, provided oversight, prioritized, and delivered the cross functional improvement initiatives and/or non-drug/clinical projects. Worked in Clinical Data management-Study database set up, conduct, DB lock activities within OC RDC, RAVE, INFORM databases, query management, Third party data reconciliation, PPC, key member of study team.