Clinical Quality Assurance/GCP AuditorВакансия в архиве

Уровень зарплаты
з/п не указана
Требуемый опыт работы:
1–3 года

The Quality Assurance Manager is responsible for Quality Assurance aspects of clinical trials, ensuring trials conform to ICH-GCP, other applicable regulations and the relevant Standard Operating Procedures


  • Plan, prepare, conduct and reporting trial specific, quality system, and vendor qualification audits to assess the quality standards and provide recommendations;
  • Execution and reporting of audits of investigator sites;
  • Preparation and Review of company SOPs required for the proper functioning of the clinical trial process;
  • Preparation for agency inspections;
  • Study documents review;
  • Provide support and advice to company departments for quality improvement;
  • Training and mentoring of internal staff;
  • Provide regular feedback to the Company Management team about the quality standards practiced in the company and give recommendations for their improvement;


  • MD or University degree in Life science;
  • Extensive GCP QA experience gained within the pharmaceutical industry;
  • Excelent communication skills;
  • Ability to proactively manage multiple responsibilities and tasks;
  • Good computer literacy with working knowledge of PCs Windows and Microsoft Office applications ;
  • Fluent English (written & spoken);
  • Able to travel on a regular basis (about 20% of work time)

We offer:

  • Challenging job in a highly qualified team
  • Employee-friendly work environment
  • Competitive salary
  • Professional growth in clinical research field

Тип занятости

Полная занятость, полный день


Санкт-Петербург, Ковенский переулок, 5
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