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Job Details:
Must Have Skills:
- Oracle Argus
- Computer System Validation
- HP ALM
Detailed Job Description:
8+ years of total experience with GxP/Validation Testing Concepts with
- Well verse with IQ/OQ/PQ concepts and hands-on with documentation and execution
- Good Knowledge on 21 CFR part 11 and its practical implementation
- Good Knowledge on GAMP Category 5 guidelines
- Hands-on with Good Documentations Practices
- Hands-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) & Documentum
- Minimum 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 bonus
Technology Experience:
Technology: J2EE / .NET
Database: SQL Server 2008 / Oracle
Tools: 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 systems
- Coordinate daily with offshr0e teams
- Deliver high quality deliverables.
