GxP Computer System Validation Specialist Wilmington - DE - Delaware

****PLEASE NOTE The rates may be negotiable based on experience, education, geographic location, and other factors..****

Qualification: Bachelor of Science OR Bachelor of Technology OR Bachelor s in Pharmacy

Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system

Knowledge, Experience and Skills:

{

CORE CSV

21 CFR Part 11820, GxP, GAMP 5, SOX, EU Annex 1122, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Auditinspection readiness, periodic reviews, access roster and audit trail reviews, DeviationCAPA management, SOPpolicy compliance processes

Authoring of URSFS, protocols, final reports, validation planreport

High-level understanding of Veeva Vault suits

Risk-based testing aligned to CSA fundamentals

}

AND

{

R&D

High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP

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