Experience may be gained concurrently and must includebr br Five 5 years in each of the followingbr Authoring computer systems validation documentationbr Applying strong organizational skills to execute and manage projects to completionbr Applying knowledge of FDA 21 CFR Part 11, 210, and 211, ICH Q8910, and EU Annex 11br br Four 4 years in each of the followingbr Performing impact assessments for laboratory system implementations and changesbr Working cross functionally with all levels of an organizationbr br Three 3 years in each of the followingbr Creation of compliance criticality assessmentsbr MS Word, Excel, PowerPoint, and MS Project.br br Experience may be gained before, during, or after issuance of advanced degree.
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