Computer System Validation (CSV) Lead

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