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Computer System Validation (CSV) Lead

Computer System Validation (CSV) Lead

Tata Consultancy ServicesThousand Oaks, CA
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  • serp_jobs.job_card.full_time
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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
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Validation Lead • Thousand Oaks, CA