Работала в 3 компаниях   24 года 7 месяцев

Фармацевтика, Другое, Образование

Standardization, certification and quality specialist, R&D Department,

Pharma Start LLC, Acino Ukraine LLC

Фармацевтика

5 лет 8 месяцев

03.2019 - по настоящее время

- making adjustments in the Module 3 “Quality” of MAD;

- knowledge of CTD requirements to structure and content of Module 2.3 “Quality overall summary” and Module 3 “Quality” of MAD;

- knowledge of guideline on biopharmaceutics classification system-based biowaivers and guideline on the investigation of bioequivalence;

- N-Nitrosamines Risk Evaluations in finished drugs;

- knowledge of Procedure under Article 5(3) of Regulation EC (No) 726/2004 Nitrosamine impurities in human medicinal products Procedure number: EMEA/H/A-5(3)/1490;

- reports on the polymorphism study (by XRPD, DSC) of the active pharmaceutical ingredients in finished drugs;

- reports on the validation of analytical methods of quality control (dissolution, related substances, assay, particles size etc.) of drug substances and finished drugs;

- reports on the compatibility of components study (active pharmaceutical ingredients, excipients and coatings) in the developing drugs;

- preparation of documents for stability studies of developed drugs in accordance with internal standard operating procedures.

Research associate, PhD

L.V. Pisarzhevskii Institute of Physical Chemistry of the National Academy of Sciences of Ukraine (IPC NASU)

Другое

18 лет 10 месяцев

05.2000 - 03.2019

- work with scientific databases;

- scientific projects development;

- preparing scientific articles and patents, presentations at the international conferences;

- synthesis and of inorganic materials with using of adsorption and spectral techniques (GC, XRPD, DSC, TGA, IR spectroscopy, TPR-H2, TPO-CO2).

Lecturer

National University of Life and Environmental Sciences of Ukraine

Образование

6 лет 3 месяца

09.2006 - 12.2012

Practical course of General and Inorganic Chemistry, supervision of Master students.

Ключевая информация

good skills in systematization and analysis of data; technical English.

Училась в 1 заведении

National Technical University of Ukraine “Kyiv Polytechnic Institute”

Chemical engineer (Chemical technologies of refractory non-metallic and silicate materials)

Київ, 2000

Владеет языками

Английский

средний

Дополнительная информация

Водійське посвідчення

B – Passenger cars

Марина

Standardization, certification and quality specialist; Regulatory affairs specialist

Киев

48 лет

Активно ищет работу

полная занятость

Характер работы: удаленная работа, гибридная, в офисе/на месте

Обновлено 3 недели назад