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Менеджер по контролю качества/Quality Control Manager

16 сентября 2024

З/П не указана

Город: Москва. Станции метро: Белорусская

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Тип занятости: Полная занятость

Требуемый опыт: Опыт от 3 лет

Обязанности:

Менеджер по контролю качества/ Quality Control Manager Responsibilities: Legislation related to laboratory testing: documents monitoring presentation updating Reference standards and reagents ordering and support of shipment: communication with Global reference standard group coordination with Global Laboratory team coordination with Global Trade Compliance communication with local partners negotiation with external laboratories (Pharmoborona, Roszdravnadzor,etc.) Paper-based testing organization: communication with local partner and support of Risk Assessment coordination with Global laboratory team/testing laboratory creating of agreements/contracts (if applicable) Virtual testing: coordination between Global Laboratory team and local laboratory slides updating (slides for laboratory, communications with laboratory) Test method transfer: coordination of the process between given and receiving laboratories cross-functional coordination with RA department to prepare all necessary activities for the TMT Support of localization process: coordination of the reference standard and reagents ordering negotiation and coordination of alternative testing (remote, paper-based, etc) Support of GMP inspections (30 %): application submissions inspection organization (site preparation, traveling, evaluation of interpreters) CAPA implementation process Requirements: Higher education (pharmaceutical, chemical, biological); 5 years Quality Assurance or Regulatory Affairs experience in the pharmaceutical industry; Upper-intermediate written and spoken English skills; Communication skills.

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