Accomplished, meticulous, and highly motivate GCP/GLP auditor with strong integrity drive to ensure quality and regulatory compliance in the pharmaceutical industry. Hands on experience in clinical monitoring in both therapeutic and oncology studies. Exposure to the clinical research process in all stages. Impressive experience in successful auditing of clinical trials (TMF, investigator site), CROs, GLP laboratories, pharmaceutical warehouses, and other research-related facilities (including internal audits) in international pharmaceutical companies demonstrating the systematic approach in GCP auditing. Proactive support and consultation with a project team on the risk management, procedures, and regulations. Precise and timely management of non-conformities, CAPA, change control in electronic QMS.• Auditing experience in GCP/GLP quality auditing in BE, Phase II - Phase IV and post-marketing clinical trials and internal audits in international pharmaceutical company.• Internal auditing of clinical department• Root cause analysis and corrective/prevention actions plans handling, management of non-conformities.• Review of main study documents (CSP, IB, ICF, etc.) and risk management activities.• Continuous support of clinical study team on the regulatory, procedural and project-related matters• Extensive experience in other GxP-related auditing activities (Good Distribution Practice, Good Laboratory Practice, ISO 9001:2015, ISO 15378:2017, ISO 17025:2019 20+ audits in total)• Management of Quality Management System elements in eQMS (TrackWise)