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1. 負(fù)責(zé)對臨床試驗(yàn)項(xiàng)目進(jìn)行稽查，確保臨床試驗(yàn)按照試驗(yàn)方案、GCP、SOP及相關(guān)規(guī)定進(jìn)行；
Audit the clinical trials to ensure the implementation in compliance with the clinical study protocols, GCP, SOP and related requirements.
2. 根據(jù)公司要求制定稽查計(jì)劃并組織實(shí)施；
Prepare audit program according to company requirements and organize the implementation.
3. 稽查工作完成后及時(shí)提交稽查報(bào)告，給出糾正和預(yù)防建議，并追蹤整改。
Prepare audit reports and define and follow up the CAPA。
4. 定期總結(jié)臨床稽查問題，及時(shí)匯報(bào)給部門負(fù)責(zé)人，并組織培訓(xùn)、討論。
Summarize and report the findings observed in GCP audits to head of QA; organize the training and discussion meeting.
5. 審核相關(guān)法規(guī)政策及相關(guān)文件的適用性及并給出建議
Review and advise on relevant guidelines, policies, company Internal Procedures etc.
6. 完成上級安排的其他工作。
Complete others tasks assigned by the superior

2. 有臨床試驗(yàn)稽查員工作經(jīng)驗(yàn)八年以上工作經(jīng)驗(yàn)；
Have GCP audit experience above 8 years experience.
3. 邏輯性強(qiáng)，細(xì)致有耐心，善于發(fā)現(xiàn)問題，富有責(zé)任感，能適應(yīng)出差。
Being logic, careful, patient, detail-oriented, responsible and like traveling.
4. 熟練應(yīng)用Excel, Word等計(jì)算機(jī)軟件；
Excellent computer skills, including Excel, Word, etc.;
5. 熟悉GCP、 ICH GCP、GXP相關(guān)法律法規(guī)將優(yōu)先考慮；
Thorough knowledge of applicable GCP and GXP regulations, guidelines, policies and procedures will be preferred.
6. 良好的中、英文書面與口頭溝通表達(dá)能力將優(yōu)先考慮。
Excellent verbal and written communication skills both in English and Chinese will be preferred.