Andriy Maslyanko
Angestellt, Lead Document Management Expert, JSC Farmak
Kyiv, Ukraine
Werdegang
Berufserfahrung von Andriy Maslyanko
Bis heute 9 Jahre und 1 Monat, seit Mai 2015
Lead Document Management Expert
JSC Farmak
- Clinical trials design (bioequivalence studies) and participation in preclinical studies - Developing medical and pharmaceutical documentation for registration (Module 2.4, Module 2.5, Modules 2.6, Module 2.7, Module 4 and Module 5) - Writing clinical study protocols, clinical protocol amendments, investigator brochures, informed consent forms - Writing clinical journal manuscripts and abstract for publication in scientific journals - Writing medical and scientific literature reviews
2 Jahre und 10 Monate, Juli 2012 - Apr. 2015
Quality Assurance Director. Qualified Person
BioTestLab Ltd.
- Ensuring the management and continuous improvement of the QA Operations and Technical Services. - Directing the review and approval process resulting in timely and technically appropriate cGMP oversight of GMP operations and documents. - Quality approval for all critical risk assessments and corresponding CAPA's. - Ensuring that all product quality related decisions adhere to current GMP and regulatory requirements. - Lead risk assessment initiatives related to Quality operations.
1 Jahr und 1 Monat, Juni 2011 - Juni 2012
Senior Research Scientist
Rhodes University
Project – “Synthesis of short chain fructooligosasccharides”
2 Jahre und 10 Monate, Aug. 2009 - Mai 2012
Post-Doctoral Research Associate
University of Western Cape
Project – “Developing thermophilic bioethanol fermentations”
6 Jahre und 2 Monate, Juni 2003 - Juli 2009
Staff Scientist
Biological Research Centre
Project – “Membrane-regulated stress response in mammalian cells”