Quality Assurance Specialist

24 uur geleden

Utrecht, Utrecht, Nederland HKU Voltijd

Quality Management Specialist

The Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform established under the LKS Faculty of Medicine (HKUMed) and dedicated to managing and facilitating international-standard clinical trials on new drugs, medical devices, and medical technologies. HKU-CTC offers long-term development opportunities to passionate talents who pursue career advancement and success.

Main Responsibilities

  • Develop and maintain a robust quality management system to ensure research quality and compliance.
  • Perform quality assurance and quality control activities to ensure adherence to international standards.
  • Facilitate participation in quality assurance and accreditation schemes to enhance the Centre's reputation.
  • Coordinate internal and external audits to ensure compliance with regulatory requirements.
  • Collaborate with the Quality Management Team to develop and implement quality management strategies.

Requirements

  • Bachelor's degree or above in Biological, Medical, Life Sciences, Quality Management, or related disciplines.
  • Minimum of 2 years' experience in clinical research quality management, monitoring, and/or project management/operations.
  • Good knowledge of Good Clinical Practice (GCP) and local/national/international regulations and guidelines related to clinical research.
  • Strong coordination and problem-solving skills, good interpersonal and communication skills, and commitment to quality and compliance.
  • Detail-minded, able to handle multiple concurrent tasks, self-motivated, and have a strong sense of responsibility.
  • Good command of written and spoken English and Chinese is a must.
  • Proficiency in Putonghua is a plus.

The appointment will be made on a two-year fixed-term full-time contract, and commence as soon as possible with the possibility of renewal subject to satisfactory performance. A highly competitive salary commensurate with qualifications and experience will be offered, together with contract-end gratuity and University contribution to a retirement benefits scheme at 10% of basic salary. Other benefits include annual leave and medical benefits.

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