Вакансія Quality assurance manager в місті Москва
Код вакансії: 619c9b3588bbff00110bca36
Вакансія закрита

Quality assurance manager

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.

Requirements:

  • 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.
ANCOR Corporate Websites
Загрузка...
Хочу в ANCOR!
Загрузка...
Заявка на услугу
Загрузка...
Logo ANCOR
Загрузка...
Logo ANCOR
Загрузка...
Logo ANCOR
Загрузка...