Arshana Mangalwadekar
Consultant-business Consulting @Infosys
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WORK HISTORY
Consultant-business Consulting @Infosys
Tools Used: HP ALM, Veeva Vault QMS, ManGo.\\\\n• Author major Project Quality/Validation deliverables (Quality plan, Validation Plan, Validation report, etc) as per RACI.\\\\n• Review and approve project System Lifecycle Documents\\\\n• Review requirement specification from a functional standpoint\\\\n• Author Change requests, review User and functional requirements, establish the traceability Matrix, Perform Gate review, and Establish change report.\\\\n• Review of Configuration specifications, Test scripts and Test Plan.\\\\n• Before Gate review ensure all the deliverables for that phase are completed and approved.\\\\n• Ensure the Test Strategy is appropriate and fit for use.\\\\n• Ensure the testing is compliant by using tools like HP ALM\\\\n• Review Test deviations/defects\\\\n• Perform Periodic review activities\\\\n• Perform GAP Analysis and ensure the closure of observations.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
ABOUT ARSHANA MANGALWADEKAR
Experienced CSV consultant with strong Pharmacovigilance background. Well-versed with…
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