湖州招聘

1. Independently manages and performs compliance audits of Contract Research Organizations (CRO), Systems and
Clinical Investigator sites for Phase I to IV clinical trials. CRO/Process Project-related audits include external
and/or internal processes such as IVRS, central labs, monitoring, data management, filing/archiving, medical
writing, GCTM, study start up, DRS etc. Lead both routine and complex directed audits. During Investigator site
audits, the incumbent has direct access to subject individual data for records review. He/she is bound by
professional secrecy and as such will not disclose any individual identity and/or individual medical information.
2. Represents CQA on various project/study team meetings. Acts as Clinical Project Quality Manager to provide
quality and continuous improvement support at the study/project level. This includes responsibilities such as: -Follow-up on progress status of assigned project(s)
- Establishment of regular contacts with operational teams -Advice and consultation on GCP and Quality issues
- Identifying and analyzing potential issues with impact on
quality
- Contribution to audit planning / programs and assistance in the monitoring of the implementation of
those programs
- Participation in the analysis of results of audits for the assigned projects
- Proposing
improvements and/or process changes
3. As requested by CQA Management may represent the sponsor during Regulatory Inspections. This will include
preparation, coordination and communication to management. Ensures adequate inspection readiness /
preparedness activities in Clinical Development
contributes to inspections as required. Ensures the establishment
of effective CAPA, and follows up timely implementation in cooperation with the audited sites, operational units
or CRO.
4. In liaison with management, manages cases of Scientific Misconduct and Serious GCP Non-Compliance. Practices
and propagates a culture of early issue detection, timely escalation and resolution on an on-going basis. Escalates
critical quality risks according to Sanofi policy (RQN).
5. When required, manages clinical auditing activities performed by external GCP QA auditors and assures CQA
Management those activities are performed in a timely manner.
职位要求：
6. Assists in the design and participate in training on CQA activities and other topics related to GCP, regulations, and
guidelines, etc.
7. Participates in the development, revision, and implementation of CQA Quality Documents, working
methodologies, tools and systems. As Sr. Auditor, be able to assess, improve and optimize current process and
practice.
Selection Process / Appendix 1 ”Job description”
8. Provides knowledge updates in areas pertaining to GCP Regulations / Guidelines / Good Practices through
review of literature and participation in relevant internal and external meetings/ workshops/symposia.
9. Supports the coaching of less experienced and / or newly hired GCP Quality Auditor(s).

赛诺菲集团
赛诺菲集团是一家全球领先的多元化医药健康企业，专注于患者需求，传播健康。
 全球100,000余名员工，业务遍及100个国家
 新兴市场实力均衡，表现强劲，位列***
 多元领域，覆盖处方药、健康药业产品、疫苗和动物保健品
 疫苗领域的领导者
 领先动物保健市场
 2011年集团净销售额达334亿欧元

赛诺菲在中国
赛诺菲是首批在中国开设办事处的跨国制药集团，也是国内增长最快的医药健康企业之一。目前，赛诺菲在中国200多个城市拥有6000余名员工。
   
传承悠久历史、持续开拓进取
赛诺菲一直以来秉承对中国的承诺。1982年，赛诺菲成为首批在中国开设办事处的跨国制药企业之一。今天，赛诺菲已跻身中国医药健康市场的领军企业。赛诺菲的中国总部位于上海，并在北京、天津、沈阳、济南、上海、杭州、南京、武汉、成都、广州和乌鲁木齐共设11家区域办公室。

独特的医药健康产品系列、满足中国公共卫生需求
从预防到治疗，赛诺菲全方位满足中国的公共健康需求。集团的疫苗事业部赛诺菲巴斯德是中国领先的疫苗企业。赛诺菲在心血管/血栓、糖尿病、肿瘤、内科和中枢神经系统等关键的治疗领域拥有领先产品。2010年，杭州赛诺菲民生健康药业有限公司的成立标志着赛诺菲进入中国的非处方药市场。2011年2月，赛诺菲完成了对BMP太阳石的收购。

大幅投资工业建设、满足中国市场需求
赛诺菲目前在中国拥有六家生产基地，包括北京制药工厂、杭州制药工厂、杭州赛诺菲民生健康药业工厂、南昌梅里亚动物保健工厂、深圳赛诺菲巴斯德疫苗工厂、以及唐山健康药业工厂。

完善的研发架构、双赢的研发合作模式
在中国，赛诺菲具有从药物靶点发现到后期临床研究的整体研发实力。集团在上海设有中国研发中心和亚太研发中心，并在北京和成都分别设有研发机构。自2008年以来，赛诺菲与中国权威科研机构开展了10多项战略合作，在癌症、干细胞、糖尿病和老年疾病等前沿研究领域探索创新药物

依托于强劲的研发能力和多领域领先水平的广泛的医药产品资源，公司在中国的市场份额不断攀升，公司规模不断扩大，飞速发展的业务给了我们与更多优秀人才合作的机会。

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