Quality Assurance Specialist
3 weken geleden
Quality Management Specialist Role Overview
The Clinical Trials Centre (HKU-CTC) is a leading clinical trials management platform dedicated to managing and facilitating international-standard clinical trials on new drugs, medical devices, and medical technologies.
HKU-CTC's Quality Management Team (QMAT) is seeking talented individuals who are interested/experienced in practising the quality management profession in the clinical research domain.
Main Responsibilities:
- Perform quality management for HKU-CTC and the clinical study activities under HKU;
- Maintain a robust QA system;
- Develop and maintain standard operating procedures;
- Facilitate participation in quality assurance and accreditation schemes; and
- Perform internal QC and coordinate external audits/inspections.
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 in 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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