Roles & Responsibilities
·Perform System Assessment, Data Integrity Assessment, Third-party Risk Assessments
·Change Record Management in CCMS and ServiceNow
·Author all Validation Documents - Validation Plan, Validation Summary, Data Migration Plan , Requirement Spec, Design Spec, Requirement Traceability, IQ and OQ protocols, System SOP
·Work with Test Leads to ensure test coverage for all requirements
·Review Test Cases to ensure test cases design 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 IQ and OQ scripts approved in ALM
·Work with Amgen Quality, SO and BO to ensure -
·i. compliance requirements are met
·ii. Change Records are approved
·iii. All Validation documents are reviewed and approved
·
Computer System Validation (CSV) Lead • Thousand Oaks, CA
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