Jobs Description
RTh - Y Total Yrs of Exp 6 Years Rlev Yrs of Exp 3+ years Mandatory Skills Validation Planning, Quality Assurance, Compliance Analyst, Experience in CSV Practices, Experience in GAMP5 CFR Detailed JD:We need a resource with CSV / SDLC experience. Resource should be an expert in validation and compliance of Pharma processes, active involvement in qualification and documentation of applications and tools Skills Required: Quality Assurance, Compliance Analyst, Experience in CSV Practices, Experience in GAMP5 CFR Part 11Main activities to be performed in GxP testing are as below � Validation Planning: Based on System Risk assessment and Data Classification assessment create the validation plan � Design Build and Test: Perform IQ, OQ and PQ Based on the validation plan � Validation Reporting: Create the Test Summary Reports and Release Notes documenting details of the testing performed including open defects if any � Validation Maintenance: In This Patch Deployments testing, Post Prod fixes testing, Enhancements testing, and New Features testing will be performed considering the GxP impact NOTE: Resource should have experience on IT side, we are not looking for manufacturing experience or only quality side experience. Experience in validating ServiceNow application is required. This role will write high quality validation deliverables.". Note - Resource need to ready for F2F Intv at IBM location based on account request and Day 1 reporting from DOJ.