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