大庆招聘

-JOB DESCRIMP/NIMPTION（Quality Specialist）
Job Title*: Quality Specialist Manager’s Title: CROM (quality)
JOB PURPOSE:
Develop quality control process for assigned projects, implement quality control process during the conduct of
clinical trials and support Pre-Approval Inspection (PAI) preparation activities to ensure PAI readinsess in the
Clinical Study Unit.
ORGANIZATIONAL CONTEXT:
(See Organizational chart attached)
SUPERVISED RESOURCES:
KEY ACCOUNTABILITIES:
-Develop and implement local quality control process
-Develop and implement quality control plan for assigned projects
-Identify and assess risks through in-house document review and on-site quality control visit, work out corrective & preventive actions to mitigate the risks and ensure proper implementation of the actions by project management team and site monitoring team
-Support monitoring team and project management team for preparation of study audits and ensure proper implementation of corrective actions & preventative actions proposed by CQA
--Contribute to the development of Study Risk Management Plan (SRMP) and monitor the implementation from quality perspective
-Lead the Pre-approval Inspection activities in CSU and act as the main contact person with Q & CI team.
-Liaise with monitoring team to prepare pre-approval inspections
-Escalate serious GCP non-compliance /scientific misconduct activities to Q&CI and participate in investigations when necessary
-Participate in local GCP inspections
-Work closely with monitoring teams to manage non-compliance and quality issues
Assist in planning corrective/preventive actions, as applicable
职位要求：
-JOB-HOLDER ENTRY REQUIREMENTS:
Education:
Bachelor Degree in Science or equivalent
Experience & knowledge:
Good knowledge of spoken and written English
Minimum of 4 years of experience in clinical monitoring.
In-depth knowledge of SOPs, CRF, ICH/GCPs.
.
Core competencies:
Good organizational, interpersonal and communication skills
Good judgement and decision-making skills
Strong influencing and negotiation skills
Ability to work in matrix teams in an open and professional manner
Strong organizational/prioritization skills for the management of multiple concurrent projects.

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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