Verily

Computer System Validation

Gilead Sciences

Validation Engineer

Relypsa

Validated the enhancements activities for Pilgrim EDMS v10.0 (Electronic Data Management System), ComplianceWire LMS (Learning Management System) SSO configurations, and TransPerfect eTMF (electronic Trial Master File) custom reports.

Validation Specialist

Qualification and commissioning of multiple Infrastructure applications and their components i.e., hardware, software, networks, data centers and related tools used to develop, test, operate, monitor, manage and/or support information technology services at Gilead Sciences

Infrastructure Qualification Engineer 

Validation of ePharmaSolutions - Clinical Trail Portal (CTP) system containing Safety Letter Distribution (SLD), eTMF (electronic Trial Master File), Learning Management System (LMS), Secure Document Repository (SDR) and User Management Administration (UMA) modules.

Clinical Validation Analyst

REXER PHARMA PRIVATE LIMITED

Validation Analyst 

Experienced Validation Engineer with a demonstrated history of working in the biotechnology industry. Skilled in Change Control, Quality System Compliance, IT Infrastructure Management, GxP, and Corrective and Preventive Action (CAPA). Strong quality assurance professional with a Master's degree focused in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University. 

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Manasa Karnati

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