- 负责对临床试验项目进行稽查,确保临床试验按照试验方案、GCP、SOP及相关规定进行; Audit the clinical trials to ensure the implementation in compliance with the clinical study protocols, GCP, SOP and related requirements. 2. 根据公司要求制定稽查计划并组织实施; Prepare audit program according to company requirements and organize the implementation. 3. 稽查工作完成后及时提交稽查报告,给出纠正和预防建议,并追踪整改。 Prepare audit reports and define and follow up the CAPA。 4. 定期总结临床稽查问题,及时汇报给部门负责人,并组织培训、讨论。 Summarize and report the findings observed in GCP audits to head of QA; organize the training and discussion meeting. 5. 审核相关法规政策及相关文件的适用性及并给出建议 Review and advise on relevant guidelines, policies, company Internal Procedures etc. 6. 完成上级安排的其他工作。 Complete others tasks assigned by the superior
任职资格
- 大学本科以上,生物、医学或药学相关专业(或相当的经验学历); Bachelor degree in biological sciences, medicine or pharmacology (or an equivalent mix of education and experience) 2. 有临床试验稽查员工作经验八年以上工作经验; Have GCP audit experience above 8 years experience. 3. 逻辑性强,细致有耐心,善于发现问题,富有责任感,能适应出差。 Being logic, careful, patient, detail-oriented, responsible and like traveling. 4. 熟练应用Excel, Word等计算机软件; Excellent computer skills, including Excel, Word, etc.; 5. 熟悉GCP、 ICH GCP、GXP相关法律法规将优先考虑; Thorough knowledge of applicable GCP and GXP regulations, guidelines, policies and procedures will be preferred. 6. 良好的中、英文书面与口头沟通表达能力将优先考虑。 Excellent verbal and written communication skills both in English and Chinese will be preferred.