Summary: Seeking an experienced CSV/CSA Consultant to support validation of SaaS and enterprise systems in a GMP environment. This role involves cloud system validation, equipment qualification, and ensuring compliance with FDA and global regulatory standards.
Roles & Responsibilities:
Validate SaaS and enterprise systems (Oracle Fusion Cloud ERP, serialization systems, eQMS, EBR) Perform CSA-based validation, release impact assessments, and system integrations Execute IQ/OQ/PQ for manufacturing and lab equipment Author and execute validation documents (URS, FRS, IQ/OQ/PQ, RTM, VSR) Ensure compliance with CFR Part , GAMP , Annex , and data integrity Support audits, inspections, change controls, deviations, and CAPAs Education & Experience :
Bachelor's degree in Engineering, Life Sciences, or related field –+ years of CSV experience...