Computer System Validation (CSV) and GxP Compliance Specialist (Pharma)

We need a pharma compliance specialist to lead GxP documentation for an AI healthcare platform preparing for enterprise pharma vendor audits. Two workstreams: uplift roughly 20 existing security and compliance SOPs to pharma document-control standards plus draft about 10 net-new ones, and produce a Computer System Validation package (validation plan, requirements traceability matrix, validation and test matrix, and test results). Note: CSV here means Computer System Validation, not comma-separated files. You should have hands-on CSV experience in pharma or biotech, deep knowledge of GAMP 5, 21 CFR Part 11, GxP, and ALCOA+, and deliverables that held up under FDA or pharma supplier audits. Experience validating AI or ML systems is a strong plus. Fast engagement, about 1 to 2 weeks.