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Must Have Skills:Oracle ArgusComputer System ValidationHP ALMDetailed Job Description:
8+ years of total experience with GxP/Validation Testing Concepts withWell verse with IQ/OQ/PQ concepts and hands-on with documentation and executionGood Knowledge on 21 CFR part 11 and its practical implementationGood Knowledge on GAMP Category 5 guidelinesHands-on with Good Documentations PracticesHands-on with preparation of Validation plan, Test approach, Test Summary Reports, Risk assessment, Change Control, Traceability Matrix and all relevant validation documents.Minimum of 4 years of experience in Oracle Argus Safety, HP-ALM (along with eApprove Process) & DocumentumMinimum of 3 years of experience in leading Testing Teams in the above-mentioned areas.Industry Experience:Working knowledge on Black-Box Testing following the Waterfall model and Agile Methodology as well.Working knowledge on test data support, Functional Testing, Regression Testing, Smoke Testing and UAT Support as well. Working knowledge with Oracle Argus Safety along with HP-ALM (including eApprove process) & Documentum.Working with life sciences companies/clients in the quality domain w.r.t compliance (GxP) and computer systems validation requirements.Proven ability to work independently in a dynamic environment.SQL knowledge is a bonusTechnology Experience:
Technology: J2EE / .NETDatabase: SQL Server 2008 / OracleTools:  HP QC 11.0/ ALM 11.5, HP UFT , JIRA, Documentum
Minimum years of experience: 5+
Top 3 responsibilities you to shoulder and execute:Work closely with client on Validated systemsCoordinate daily with offshr0e teamsDeliver high quality deliverables.