| CSV Engineer at Remote, Remote, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1372573&uid= From: Arun kumar, yochana IT [email protected] Reply to: [email protected] CSV Engineer Raritan, NJ Hybrid(2 days a week) Contract Profiles Needed Keywords CSV, Computer System Validation, AP ECC/S4 HANA validation, Solman/ChaRM Change management, Roles and Responsibilities 7+ years of CSV experience with exposure in SAP ECC/S4 HANA system validation, Solman/ChaRM change control process, JIRA/XRAY/qTEST tools for validation required. Working Knowledge of regulations: 21 CFR Part 11 and Annex 11 Understanding of quality risk-management concepts (ICH Q9) and adept in applying Good Manufacturing Practices principles Experience in systems validation and quality frameworks and risk based quality approach Perform quality review of relevant validation documentation pre and post execution for accuracy, completeness and ensures compliance with regulatory and client requirements. Experience in executing change control and document management Knowledge of GAMP5 and Quality Systems Experience on decommission, Archiving and Data Integrity (ALOCA+) Prior experience in using of tools like qtest, Document Management system (EDMS), ServiceNow and JIRA Experience in computer systems validation, GXP regulatory knowledge with good documentation methods and CSA approaches and risk-based validation required. Test automation tools and methods, authoring and/or reviewing validation deliverables such as Compliance Plan, Summary Report, Test Protocols, Test Scripts, Requirements and Trace Matrix is required. Experience working in Agile methodology and tools is required. Keywords: sfour information technology New Jersey CSV Engineer [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1372573&uid= |
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| 05:46 AM 07-May-24 |