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Validation Lead
Validation Lead
Menlo Park, CA

Validation Lead

-    Validation Lead/ Senior Validation Engineer
-    Author, manage reviews of and route validation documentation for initial implementation of systems and periodic system change management
-    Manage the validation workstream for projects
-    Provide timelines for the validation workstream of projects
-    Systems – Veeva Vault (quality docs, CRM, regulatory submissions), Tracelink, middleware, LMS, Process verification for manufacturing, drug safety - Systems in research and product development area)
-    Local candidate who can work 40 hrs. a week
Validation documentation include:
o    System Regulatory Applicability Assessments
o    System Level Risk Assessments
o    Validation/ Qualification Plan
o    System Requirements Specifications – URS/FRS/DS/CS
o    Protocols – IQ, OQ, PQ, DQ
o    Protocol execution
o    Test coordination
o    Deviation management
o    Summary reports (Test, Data migration, Validation)
o    Training Plans
o    Trace Matrix
o    Change Controls

 

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