Manasa Karnati
Computer System Validation at Verily- Claim this Profile
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Bio
Credentials
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Certified ScrumMaster (CSM)
Scrum AllianceNov, 2021- Nov, 2024
Experience
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Verily
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United States
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Hospitals and Health Care
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700 & Above Employee
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Computer System Validation
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Dec 2022 - Present
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Gilead Sciences
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United States
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Biotechnology Research
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700 & Above Employee
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Validation Engineer
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Aug 2018 - Dec 2022
Biovia LIMS Biovia LIMS
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Relypsa
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United States
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Biotechnology Research
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1 - 100 Employee
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Validation Specialist
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May 2018 - Aug 2018
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. 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.
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Gilead Sciences
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United States
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Biotechnology Research
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700 & Above Employee
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Infrastructure Qualification Engineer
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Apr 2016 - May 2018
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
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Clinical Validation Analyst
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Nov 2013 - Apr 2016
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.
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REXER PHARMA PRIVATE LIMITED
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India
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Mining
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Validation Analyst
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Aug 2010 - Nov 2011
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Education
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Northeastern University
Master's degree, Regulatory Affairs for Drugs, Biologics, and Medical Devices -
Jawaharlal Nehru Technological University
Bachelor's degree, Bachelors in Pharmacy