Quality Assurance ManagerВакансия в архиве

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Уровень зарплаты
Город
Требуемый опыт работы
з/п не указана
Москва
3–6 лет

Job Responsibilities:

  • Deviation management: proper documentation, communication with the stakeholders, all related processes control;
  • Recall handling: proper documentation, communication with the stakeholders (wholesalers; Authorities, WH), all respective process control. Mock recalls;
  • Development and implementation of the SOPs for respective processes in accordance with the local legislation requirements, international quality requirements and company SOPs;
  • Preparation/reconciliation/approval of the training materials and presentations for respective SOPs, due trainings performance control;
  • Participation in the external and internal audits, reports drafting/reconciliation/signatures collection;
  • Maintenance of QMS webpage on Takeda Russia intranet. Creation of the scope, development process management, communication to the respective stakeholders. Duly documents update at the webpage. Keeping Takeda Russia employees informed on the QA updates and employees support in using it;
  • Identification of the transportation processes Takeda, Russia/CIS is responsible for. QAA signing with the transportation companies, if applicable;
  • SOPs drafting support for GxP depts;
  • Contracts with in-license partners revision to check if the QA topics are addressed, responsibilities are defined;
  • Partnership with contract manufacturer if any, cooperation processes with the contract manufacturer analysis; QAAs if any;
  • CIS colleagues support on QAAs signing, recalls, deviations;
  • Quality issues management.

Requirements:

  • High Professional Education (pharmaceutical/chemical)
  • Relevant experience from 3 years
  • English language – advanced level in written and oral communication
  • Ability to work in a multitasking environment with strict deadlines

Адрес

Москва, Усачева улица, 2, бизнес-центр "Фьюжн Парк"
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