Тип вакансииОткрытая
ОпытОт 3 до 6 лет
Тип занятостиПолный день Полная занятость
СпециализацииМедицина, фармацевтика - Провизор
Медицина, фармацевтика - Производство
Медицина, фармацевтика - Лекарственные препараты
Производство, сельское хозяйство - Фармацевтическая промышленность
Описание

Responsibility:

  • To check the compliance of each imported batch with regard to the approved normative document (ND)/RU Pharmacopeia based on the certificate of analysis (CoA) issued by the manufacture of the medicinal product;

  • To check, confirm and document the compliance of each imported batch with the requirements of the relevant product marketing authorization in Russian Federation;

  • To provide Rozdravnadzor with all information in accordance with the requirements in the Federal Drug Law as the precondition to be fulfilled prior the distribution of the batch in the territory of the Russian Federation;

  • To organize the local control of the first 3 batches of a newly imported product and provides Rozdravnadzor with the results;

  • Responsible for archiving all relevant documentation according to company rules;

  • To report in time to Rozdravnadzor and company decisions to stop further production (timely limited or forever);

  • Submission of Quality test protocols for each imported product

  • Conducts self-inspections to departments with have relations to the distribution of the products;

  • Propose actions to improve the Quality Management System and lead the implementation.

Requirements:

  • Higher medical education;

  • Quality experience: 3 years or more;

  • English – upper-Intermediate or higher;

  • Excellent communication skills.


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