Proflie: A highly efficient and systematic Clinical Quality Assurance professional with 17 years of experience in the pharmaceutical industry, including 14 years working in Clinical Trials and 11 years in QA. AREAS OF EXPERTISE are Quality Management Systems (QMS) ,Quality Assurance (QA), Auditing (Investigator sites, process, system, TMF, and vendors audits) Quality Control (QC) ,Hosting of External Audits and Regulatory Inspections, Corrective and Preventive Actions (CAPA) development, Root Cause Analysis, Risks identification, assessment, and management SOPs and instructions development, GCP training and educational activities ,Quality Assurance plans preparation Training. Types of audits conducted: GCP audits include audits of vendors working in the GCLP and GDP which participated in the clinical trials under the scope of the audits. Current City: Barcelona, Spain. Countries covered :EU, Turkey, Serbia, Israel, Africa, Russia, Georgia, USA. Language Expertise: Russian, English (fluent), Spanish(B2).