Maria Saraeva
Angestellt, Quality Control Specialist, Takeda Pharmaceuticals
Abschluss: Master degree in Chemical technology of organic substances, Yaroslavl State Technical University
Singen, Deutschland
Werdegang
Berufserfahrung von Maria Saraeva
Bis heute 10 Jahre und 1 Monat, seit Mai 2014
Quality Control Specialist
Takeda Pharmaceuticals
Support of Regulatory Affairs and LOCs in registration dossier preparation and submission (RUS, CIS, CHN Markets), CMC-documents preparation, review, approval, CDT-dossier review; Artworks and mock-ups management (RUS, CIS, CHN Markets), handling of computerized systems (EAMS, EQMS, SAP); Change control handling, Deviation handling, CAPA handling; Supplier evaluation; GMP docs management (e.g. Expert statements, SOPs, Specifications, Comparative dissotution profiles creation, review and approval)
11 Monate, Juli 2013 - Mai 2014
Chemist
Takeda Pharmaceuticals
Main functions: bulk and finished product testing, climatic chambers management, GMP documentation management, temperature and humidity monitoring, preparation of employees’ laboratory timetable.
1 Jahr und 3 Monate, Apr. 2012 - Juni 2013
Engineer
OrgChemTech Ltd
Main functions: R&D, testing of raw, intermediate, auxiliary materials and finished products, trial testing of growth-regulating chemicals, documentation management.
Ausbildung von Maria Saraeva
1 Jahr und 11 Monate, Sep. 2011 - Juli 2013
Pharmaceutical chemistry
Yaroslavl State Technical University
4 Jahre und 11 Monate, Sep. 2008 - Juli 2013
Chemical technology of organic substances
Yaroslavl State Technical University
Sprachen
Englisch
Fließend
Russisch
Muttersprache
Deutsch
Grundlagen