C2C Position: CSV Consultant with GxP Location: Wilmington, DE

Position: CSV Consultant with GxP

Location: Wilmington, DE

Duration: 12 months Contract

Job Description:

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 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes
Authoring of URS/FS, protocols, final reports, validation plan/report
High-level understanding of Veeva Vault suits
Risk-based testing aligned to CSA fundamentals
High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP
 

Education: At least a bachelor s degree (or equivalent experience) in Computer Science, Software/Electronics Engineering, Information Systems, or closely related field is required