Senior QA Auditor (GCP Audits) - Certified to Audit Sites in Italy
Core
Plan and conduct independent clinical (GCP) audits to assess compliance with regulations and guidelines for clinical research programs.
Role type
Senior QA Auditor (Clinical Trials)
Builds
Compliance reports, CAPA plans, and audit findings for life sciences clients
Domain
Life Sciences / Clinical Research / Quality Assurance
Required skills
GCP audit execution, Investigator Site Audit (ISA) experience, Italian regulatory certification, Root Cause Analysis, CAPA management, eQMS maintenance, regulatory interpretation
Preferred skills
Training new QA staff, hosting regulatory inspections, process improvement initiatives
Technologies
eQMS, word-processing, spreadsheet, database applications
Responsibilities
Plan, schedule, conduct, and close audits across European countries; Evaluate audit findings and prepare reports; Provide consultation on regulations and policies; Review and approve investigations, RCA, and CAPA plans; Perform pre-inspection visits; Maintain eQMS; Lead QA initiatives and process improvement projects
Seniority
Senior, hands-on IC
