Scope of responsibilities:

1. Participate in clinical trial audits to ensure the QA system. Have experience in auditing clinical trials, especially those in research centers. Capable of carrying out systematic audits to identify problems in operation department processes and operational aspects, and provide feedback to the management;

2. Carry out independent audits of overseas research center for international multicenter projects, able to communicate and submit audit reports in English;

3. Familiar with audit processes including audit planning, execution, report submission and reply and follow-up to audit review reports;

4. Follow up on audit findings, coordinate relevant departments in CAPA formulation, understand how to formulate and independently audit CAPA for the closure;

5. Take part in the formulation and execution of interior audit plans;

6. Regularly summarize the problems in audits and communicate with managers to formulate corrective actions.

Requirements:

1. Bachelor’s degree or higher in Medicine, Pharmacy, Biology or other relative fields;

2. Over 3 years’ experience in QA or over 5 years’ experience in CRA, QA or CRA experience in foreign companies is preferred，specially considered if excellent;

3. Good English writing and communication skills;

4. Proficient Microsoft office skills;

5. Good communication skills and ability to coordinate, careful and patient in work, good reading and writing skills.