Sameer Sethi

Senior Regulatory Consultant @LORENZ Life Sciences Group

Easton, PA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jun 2013 — Present

Senior Regulatory Consultant @LORENZ Life Sciences Group

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Assisting clients with the troubleshooting of Regulatory softwares (docuBridge, eValidator, Automator) remotely-Supporting the installation, administration and implementation of LORENZ products and its integration with different docbases e.g Veeva Vault, Cara, Qumas, Sharepoint, D2, Documentum, Next Docs etc -Assisting clients with technical, post implementation and product functionality inquiries-Investigating applications issues experienced by the user community and collaborating with the developers to diagnose the root cause of the issue-Using the deep understanding of the regulatory environment of LORENZ products, and apply that knowledge to help clients better leverage the products-Perform installation, validation, configuration and migration related services -Executed, industry specific technical activities, such as: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities associated with Software Validation requirements-Provided inter-departmental assistance for similar technical activities within the company -Assisting clients with submission assembly, publishing and validation activities - Database Administration of MS SQL Server and/or Oracle - Service Oriented Architecture (SOA)- Maintenance of Client-server applications, virtualization platforms, database systems (SQL), cloud-based systems (AWS )

SKILLS

Service DeskGxpCore DossierPharmaceutical IndustryTroubleshootingIT Service ManagementFirstdocPublishing and Rendering ToolsChange Management21 Cfr Part 11IT OperationsLotus NotesRegulatory RequirementsProcess ImprovementRegulatory SubmissionsVendor ManagementVmwareSopSystem DeploymentIT ManagementDisaster RecoveryItilRemedy Ticketing SystemVisioSharepointQuality AssuranceHardwareSoftware DocumentationBmc RemedyCtdDocument ManagementCitrixValidationManagementTechnical SupportAnalysisData ManagementProject Portfolio ManagementWindows 7Documentum

ABOUT SAMEER SETHI

Technical Expertise: Proficient in providing technical support with a focus on…

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