Computer System Validation

4 weeks ago


Thousand Oaks, United States Tata Consultancy Services Full time
Roles &Responsibilities
•Perform System Assessment, Data IntegrityAssessment, Third-party Risk Assessments
•Change Record Management in CCMS andServiceNow
•Author all Validation Documents - ValidationPlan, Validation Summary, Data Migration Plan, Requirement Spec,Design Spec, Requirement Traceability, IQ and OQ protocols, System SOP
•Work with Test Leads to ensure testcoverage for all requirements
•Review Test Cases to ensure test casesdesign and Execution are performed as per Good Practices(GP) guidelines
•Support UAT test cases design and execution
•Work with System Owner(SO) to get all IQand OQ scripts approved in ALM
•Work with Amgen Quality, SO and BO toensure -
•i. compliance requirements are met
•ii. Change Records are approved
•iii. All Validation documents are reviewedand approved


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