Vishal Jagtap M. Pharm

Manager Gcp Qa Drug Safety and Risk Management @Lupin

Pune, IN

Develop and prioritize an audit strategy for all Global Clinical programs.Plan and lead GCP compliance audits (India and international), including but not limited to clinical investigator sites, data management, clinical study reports, trial master files, contract clinical laboratories, clinical warehouse,contract research organizations (CROs), process and system audits to determine compliance status and identify compliance risks.Responsible for Report audit findings to management with recommendations for resolution and verify appropriate corrective and preventive actions have been implemented and documented.Partner with Clinical Development, Clinical Operations and Regulatory Affairs stakeholders regarding compliance issues and provide compliance guidance to audited parties to encourage process improvement, serve as an expert in the interpretation of GCP regulatory requirements and expectations.Perform QA review of project‐related essential clinical study documents.Lead training activities for continuous improvement and quality enhancement of clinical development and QA activities.Develop and implement standards, policies, and procedures for Clinical Operations QA activities.Participate in quality and compliance improvement initiatives within and outside of Clinical Development/Operations.Participate in the evaluation and selection of CROs and other clinical and nonclinical service providers.Provide guidance, interpretation and information on GCP regulations, standards and quality systems.Prepare internal QA reports, and provide input for external partner’s reportsPartner with external auditor for conducting audits when applicableHosting regulatory authority inspections and the coordination of responses to resolve inspection findings, if anyResponsible for pre-inspection audit preparation and readiness audits and activities

JJT University

Ph. D, Pharmaceutical Sciences

Mumbai University Mumbai

m pharmacy, Pharmacy