Über diesen Experten

Senior Validation Engineer with 8 years of experience in Computerized Systems Validation (CSV) within GMP-regulated pharmaceutical environments. Experienced across the full validation lifecycle, including validation planning, risk assessments, requirements review, IQ/OQ/PQ, traceability, validation reports, periodic reviews, change control, CAPA support and audit readiness. Experienced with enterprise, laboratory, manufacturing and infrastructure systems. Skilled in developing compliant validation documentation and working with QA, IT, Engineering, Manufacturing, Automation, suppliers and business stakeholders. Available for remote freelance and project-based CSV/GxP validation and quality documentation support.