Lead specialist of standardization, certification and quality
Quality manager of the testing laboratory
- Master’s degree in Biology and Biochemistry – Taras Shevchenko Kyiv State University,
- Postgraduate Training on the Program “Laboratory genetics” – National Medical Academy of Postgraduate Education. P.L. Shupika Ministry of Health of Ukraine,
- Postgraduate Training on the Program “Management and Logistics” – NationalAviation University (NAU),
- More than 12 years’ experience in quality sphere – development, implementation, maintenance and auditing of the Quality Management Systems according to the ISO 9001, ISO 13485, ISO 22000, HACCP, IFS; implementation of ISO/IEC 17025 in the practice of production testing laboratory and its accreditation.
- Experience in the medical devices conformity assessment sphere- 3 years.
- Carried out more than 90 audits of quality management systems of domestic and foreign enterprises.
- Free proficiency in Ukrainian, Russian and English.
Certificates of competence in the field of medical devices conformity assessment:
- Lead Auditor on the standard ISO 13485 – Certificate No. UNI-CERT.11-16 dated 19.08.2016 (LLC “UNI-CERT”, Kiev).
- Lead auditor of quality management systems on the standard ISO 9001: 2008 – Certificate SGS/SSCE/QMSLAC/600270/F/28068 dated 08-12.08.2011 (SGS Ukraine, Odessa).
- Internal auditor in accordance with ISO/IEC 17025 and ISO 19011 – Certificate No. TCL/2016/02-011 dated 03.02.2016 (Fortius Quality Group, Kyiv).