Hanna Serdiuk

Experience

• 

  National Academy of Sciences of Ukraine

  Jul 2006 - Feb 2020

  • Researcher (L. M. Litvinenko Instituteof Physical-Organic Chemistry)

    May 2016 - Feb 2020

  • Junior researcher (L. M. Litvinenko Institute of Physical-Organic Chemistry)

    Nov 2015 - Apr 2016

  • Junior Researcher (Institute of Organic Chemistry)

    Nov 2014 - Oct 2015

  • Junior researcher (L. M. Litvinenko Institute of Physical-Organic Chemistry)

    Jul 2006 - Oct 2014
• 

  Kazan National Research Technological University

  May 2015 - Jul 2015

  Visiting Researcher
• 

  Gemini PharmChem Mannheim GmbH

  Mar 2020 - now

  Main responsibilities:* managing of the quality control department and supervisory staff* monitoring of QC activities compliance with the requirements of GMP & regulatory documents* monitoring and control of the QC laboratories environment according to HSE rules* establishing and monitoring of key performance indicators (KPIs) and metrics for QC activities* presentation of QC-related topics / QC department within authorities / customers inspections* managing of analytical method development and validation* handling of OOS, complains, QC-related deviations and change controls* CAPA establishing and implementation* preparation and authorization of written procedures (SOP/OP) and other GMP documents* approval, control and monitoring of supplied of materials quality* approval, control and monitoring of produced materials (APIs) quality* approval and monitoring of providers of other QC-related outsourced activities/services* designation of storage conditions for materials and final products* establishing of stability programs and stability data evaluation* preparation of QC-related chapters for regulatory submissions & answers on regulatory requests* participation in management reviews of process performance, product quality and the quality management system and advocating continual improvement Show less

  • Deputy Head of Quality Control

    Apr 2023 - now

  • QC Chemist

    Mar 2020 - Mar 2023