Quality assurance manager

з/п не указана

Москва, Деловой центр, Деловой центр, Международная

Требуемый опыт работы: более 6 лет

Полная занятость, полный день

Tasks:

  • Development and implementation of the Clinical Operation Plans, Logs, update and create SOPs for the quality relevant processes in accordance with the local legislation requirements, international quality requirements ICH-GCP.
  • Preparation/reconciliation/approval of the training materials and presentations, control of timely trainings performance on the ICH-GCP and SOPs. Develop and implement the procedures according to the QA requirement and standards for Clinical Operation department;
  • Quality Improvement Plans/management reviews preparation;
  • Leading external and internal audits of the company’s QM reports drafting/reconcilication/signatures collection;
  • CAPA implementation as a result of the audit monitoring;
  • Change management of the clinical operations documentation and SOPs ;
  • Leading the (potential) suppliers/partners/distributors assessment/maintenance process including audits performance, reports compilation, CAPA implementation monitoring, development and signing of the QAAs; Quality Assessment of the third part vendors
  • Timely reporting
  • To be guided by the corporate Compliance and Ethical principles
  • To populate the Quality Management System with reports, records, audits and procedural documentation relating to the performance and operations Sections.

Successful candidate should have

  • More than 10 years experiences in the clinical research industry

  • Medical or biological background would be highly appreciated!

  • English (both written and verbal) at advanced+ level

Other

  • Direct report to Clinical Operation Head

  • Nice view from 38th floor of Federation Tower at Moscow City

What we offer

  • Dynamic environment, variety of nonstandard tasks and opportunity to use different approaches

  • Career opportunities

  • Salary is discussed with a successful candidate individually.

Ключевые навыки

Английский язык
Quality Control

Вакансия опубликована 16 ноября 2021 в Москве

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