Olena Vinnyk

o Coordination and participation in GMP inspections o Management of Quality agreements/SDEA o Documentation management o Risk Management o Management of outsourced activities o Change management o Deviation management o Audits (internal/external) o Coordination of CAPA o Scheduling and conducting trainings o Taking part in global PV audits o Updating PSMF on local level

Development and implementation of quality management system in accordance with GMP, GDP and ISO 9001, ISO 13485 requirements Analysis, improvement and optimization of Company`s processes Management of documentation Management of customers complaints Planning and conduct internal and vendor audits Investigation of the deviations, claims Сhange control management Quality risk management Planning and conducting training Analysis of the functioning of QMS Work with external auditors (state bodies, partners)