
Mitul Patel
Drug Metabolism and Pharmacokinetics

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About me
Tech-savvy Quality Professional with 10+ years in GxP (GLP, ICH GCP, VICH GCP). Expertise in Veeva, Continuous Improvement, audit oversight, QMS management, CSV, Vendor Assurance, and Quality Metrics
Education

Rajiv Gandhi University of Health Sciences
2007 - 2009Master's degree M.Pharm (Pharmacology)
Experience

Torrent Research Centre
Jun 2009 - Sept 2017Drug Metabolism and Pharmacokineticspre-clinical and clinical research of NCEs

Elanco
Apr 2018 - Dec 2022QMS Consultation,External and Internal AuditsGLP, GCPComputer Systems Validation Process Improvements GLP GCPInternal and External AuditsQMS Implementation Computer Systems Validation Study Monitoring and QC Review of Data generated for GLP (OECD), GCP (VICH) and GxP studies being conducted at Elanco (Eli Lilly And Company) Animal Health Division.
Consultant R&D Quality Assurance
Apr 2022 - Dec 2022Senior Representative R&D Qaulity Assurance
Aug 2019 - Mar 2022Study Monitor
Apr 2018 - Aug 2019

GC CRO
Dec 2022 - nowResearch Quality LeadQMS Management and Consultant, CSV and New Systems Implementation, Good Clinical Practice, Internal Audits, Vendor Assurance Management, Learning and Development, Document Controller, Veeva QMS/CTMS/eTMF - IT Admin and configuration specialist
Licenses & Certifications

Good Clinical Practice
NIDA Clinical Trials NetworkDec 2022- View certificate

Vault Platform Associate Administrator - 2024
Veeva Training ServicesJul 2024 - View certificate

Microsoft Teams Quick Tips
LinkedInJul 2023 
Introduction to Artificial Intelligence
TAFE NSWMay 2025- View certificate

Training with Stories
LinkedInDec 2023 
GCP and Clinical Trials
JoBurmester.comJan 2023- View certificate

Nano Tips to Sharpen Your Critical Thinking with Shadé Zahrai
LinkedInJul 2023 - View certificate

Generative AI Overview for Project Managers
Project Management InstituteOct 2023
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