PUpsilon Global are seeking a freelance GCP Auditor in Spain to support EMA clinical site inspection preparation on behalf of a USA-based CRO. /p pThis assignment is linked to an upcoming EMA submission, with a focus on inspection readiness. The sites are based in the US, with one site in Spain. /ppbr/ppThe ideal profile will have GCP auditing experience, strong knowledge of inspection readiness activities, and be based in Spain. /p pbResponsibilities: /b /pulliPlan and conduct assigned audits /liliPerform for cause audits as needed /liliWrite and issue audit reports, ensuring clear communication of audit findings to auditees and management /liliReview responses to audit findings for appropriateness and completeness /liliClose assigned audits /liliDevelop CAPAs as appropriate. /liliPrepare for and host/support Regulatory Authority Inspections /liliWrite/review/revise QA SOP/WI /liliProvide guidance to staff/management on quality related matters /liliContribute to creation of company QMS /liliApply critical thinking to identify solutions to non standard requests, issues and problems /liliRequire minimal instructions on day to day assignments /liliMay review vendor audit reports /liliMay provide coaching/training to company or vendor personnel /li /ulpThis project may start before the end of April. /p pFor more details please apply, contact Janet Kruger or email /p