Iryna Nekhotsa

Background

About Iryna Nekhotsa

Experienced within the pharmaceutical industry, particularly in the domains of Quality Control and Quality Assurance. Studied Industrial Biotechnology at Kyiv Polytechnic Institute. My professional journey commenced at Yuria-pharm LLC, where I assumed the role of a chemist-analyst in the QC department. This role equipped me with extensive knowledge and hands-on experience in executing numerous analytical methods. The primary focus of my responsibilities encompassed HPLC analysis of medicinal products and APIs. This position also necessitated a comprehensive understanding of GMP and associated regulations. After a span of 2.5 years, I aspired to broaden my horizons and transitioned into the QA department, undertaking the position of QA Officer. This role primarily involved overseeing the QA aspects of activities related to the certification process of Medical Devices within the Ukrainian and EU markets. This encompassed the creation and periodic updating of Technical Files, Declarations of Conformity, and other associated documentation. In addition, I actively engaged in project communication, participated in inspections, and was responsible for keeping updated MD-related regulations/standards library. At present, I am employed at PharmSupport BV in the capacity of a QA Officer. The project-based nature of this role provides me with the opportunity to contribute to diverse projects, fostering personal growth and self-improvement in various domains such as validation and qualification, developing project quality-related documentation (Policies, SOP, WI), and building internal processes. Concurrently, it requires operating within distinct regulatory frameworks such as GxP among others. This dynamic environment enables continuous professional development and an avenue for multifaceted expertise.