Bangalore (INSUBRAM) Subramanya Arcade, Grd-3rd Flrs No 12 Subramanya Arcade, Grd-3rd Flrs No 12
India
3-6 months
Time and material
$ 16-18/Hr
Description
RTH - Y Sector - Distribution No of Position - 1 Detailed JD - 5+ yrs of Exp, .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 11 Main 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, Enhanceme. Note - Resource needs to ready for F2F Intv at IBM location based on account request and Day 1 reporting from DOJ. - IBMFG2JP00015968
Skills:
CFR Part 11,Compliance Analyst,CSV Practices,GAMP5,IQ,OQ,Quality Assurance,Validation Planning
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