Quality Assurance AuditorMoscow, Russia
Since March 2015
official duties: Planning and conducting co-monitoring visits and audits (Phase I to iv Clinical studies in russia for different Therapeutic Areas: pulmonology, oncology, Rheumatology, Ophthalmology, Neurology, Infectious diseases, healthy volunteers etc.). vendor management: central laboratories and warehouses audits/ assessments. implementation and improvement of the Quality Management System. provision of internal and external trainings. acting as a gcp helpdesk for employees. hosting clients’ audits.
Official duties: planning and conducting co-monitoring visits and audits (phase I to IV clinical studies in Russia for different therapeutic areas: pulmonology, oncology, rheumatology, ophthalmology, neurology, infectious diseases, healthy volunteers etc.). Vendor management: central laboratories and warehouses audits/ assessments. Implementation and improvement of the quality management system. Provision of internal and external trainings. Acting as a GCP helpdesk for employees. Hosting Clients’ audits.
Senior CRA Moscow, RussiaFebruary 2011 --- March 2015
official duties: site administrating and site monitoring responsibility for Clinical studies. Recruiting potential investigators, preparing ec submissions, translating study-related Documentation, organizing of meetings and other tasks as instructed by Supervisor. completing sae reporting, processing production of reports. negotiating study Budgets with potential investigators and assisting legal department with statements of agreements as assigned. assisting with Training, mentoring, and development of new employees, e.g. co-monitoring. identifying new sites and drawing them in client Clinical studies. therapeutic experience: oncology, Neurology, Cardiology, Endocrinology.
Good Clinical Practice (GCP)Good Distribution Practice (GDP)Good Laboratory Practice (GLP) Phase I Scientific writingCAPAClinical monitoringClinical operationsClinical researchClinical trial audits and inspectionsClinical trialsCompliance with regulationsCROGXPICH guidelinesPharmaceutical ResearchPhases of clinical development (phase I to IV)Quality AssuranceTranslationQuality AuditingQuality ManagementQuality Management System (QMS)Standard Operating Procedure (SOP)Writing Study Procedures and SOPs
Skills and Expertise
Analytical skills Assure medical quality Create SOPsAssess quality process issuesDevelop ICH/GCP compliant processesDevelop Quality Risk Management (QRM) initiativesEnsure good clinical practice (GCP)Follow-up of external auditsFollow-up of internal auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesMaintain Quality Management System (QMS)Manage Quality Management System (QMS) documentationPrepare external auditsRespond to audit findingsReview quality control activitiesReview quality policiesSet-up quality policiesTrain Staff
Ph.D. in Biology from Lomonosov Moscow State University in 2006
Master in Microbiology from Lomonosov Moscow State University in 2003
Training and Certification
Professional Communication Translator in 2016 Training
Data Management for Clinical Research in 2017 Certification
Audit Analysis and Reporting (RQA) in 2016 Certification
Bioanalytical, statistical and regulatory aspects of Bioequivalence studies in 2016 Certification
The GDP Audit How to conduct and pass GDP Audits and Inspections (ECA) in 2016 Certification
Conflict management skills & manipulation resistance in 2015 Certification
Principles of organization and conduct of pre-clinical studies according to GLP in 2015 Certification
Quality Management System implementation and improvement in accordance with ISO 9001 in 2015 Certification
The Auditing Course (RQA) in 2015 Certification