长沙招聘

职位描述：

1. FINAL DECISION ON ACCEPTANCE FOR USE OR REJECTION OF ALL RAW MATERIALS, ACTIVE PHARMACEUTICAL INGREDIENTS, PACKAGE COMPONENTS, PRINTED PACKAGING MATERIALS, IN PROCESS PRODUCTS AND DRUG PRODUCTS . 对所有原料、活性成分、包材及印字包材、中间体和药品做最终决定接受使用或拒绝。

2. REVIEW AND APPROVAL OF STANDARD OPERATING PROCEDURES FOR CONFORMANCE TO THE CGMPS AND THEIR INTEGRATION INTO A QUALITY SYSTEM DESIGNED TO PREVENT AND CORRECT QUALITY PROBLEMS. 回顾和批准标准操作规程以确认符合 GMP要求，并整合设计到质量系统中以预防和改进质量问题。

3. REVIEW AND APPROVAL OF MASTER PRODUCTION DOCUMENTATION TO ASSURE ADHERENCE TO REGISTRATION, COMPANY STANDARDS, GMP AND VALIDATION. 回顾和批准主生产文件以保证符合注册、公司标准、GMP和验证等的要求。

4. MAINTENANCE AND MANAGEMENT OF TESTING FACILITIES TO ASSURE THAT RAW MATERIALS, ACTIVE INGREDIENTS, PACKAGING MATERIALS, IN PROCESS MATERIALS AND DRUG PRODUCTS MEET THEIR SPECIFICATIONS, INCLUDING ALL TEST METHODS AND MATERIAL SPECIFICATIONS. 维护和管理检验设备以保证原料、活性成分、包材、中间体和药品符合质量标准，包括所有检验方法和物料质量标准。

5. ENSURE A QUARANTINE SYSTEM TO GUARANTEE THAT INCOMING MATERIALS ARE NOT USED BEFORE APPROVAL AND FINISHED DRUG PRODUCTS ARE DISTRIBUTED ONLY AFTER RELEASE. 保证待验系统工作有效，确保不将来料在放行前投入使用和成品只有在放行后方可发货。

6. FINAL REVIEW OF MANUFACTURING AND QUALITY CONTROL DOCUMENTS (BATCH MANUFACTURING RECORDS, BATCH PACKAGING RECORDS, CERTIFICATE OF ANALYSIS) PRIOR TO THE RELEASE OF A BATCH OF PRODUCT. 产品放行前最终审核生产和质控文件（批记录和检验报告）。

7. REVIEW AND APPROVE ALL THE VALIDATION PROTOCOLS (EQUIPMENTS, SYSTEMS AND PROCESSES ETC) AS WELL AS THE VALIDATION REPORTS. 审核和批准所有验证方案（设备、系统和工艺等）及验证报告

8. REVIEW AND APPROVE THE PRODUCT QUALITY REVIEWS FOR MARKETED PRODUCTS. 审核和批准上市产品的产品质量回顾分析。

9. ENSURE THE ORGANIZATION OF INTERNAL AUDITS TO ASSURE CONFORMANCE TO CGMPS AND RELATED REGULATORY REQUIREMENTS AS WELL AS AUDITS TO CONTRACTORS/SUPPLIERS TO ASSURE THEY CAN SUPPLY PRODUCT THAT MEETS ESTABLISHED REQUIREMENTS. 开展自检以保证符合 GMP及相关法规要求，开展审计以保证合同方、供应商能提供符合要求的产品。

10. MANAGE PROCEDURES TO CORRECT DEVIATIONS AND OUT OF SPECIFICATION RESULTS AND MONITOR THE CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) TO PREVENT THE REPETITION OF THE NOT COMPLIANCE INSTANCE. ESTABLISH AND MANAGE A CHANGE CONTROL SYSTEM. 有效管理偏差和 OOS 程序并监控整改和预防性整改措施的落实以预防不符合事件的重现。建立并管理改变控制系统。

11. ESTABLISH AND ASSURE A CONTINUOUS GMP TRAINING TO MAINTAIN AN HIGH LEVEL OF GMP AWARENESS IN ALL THE STAFF. 建立并持续开展GMP培训以维护全体员工高水准的GMP意识。

12. ASSURE THE CORRECT HANDLING OF PRODUCT RECALL AND CUSTOMER COMPLAINTS. 保证正确处理产品召回和客户投诉。

13. CONTROL OF RETURNED NON-DEFECTIVE PRODUCTS BEFORE REINTRODUCTION AND DISTRIBUTION INTO THE MARKET WHEN APPLICABLE。对质量未受影响的的退货，对重新进入流通渠道进行质量控制。

14. ESTABLISH A STABILITY PROGRAM FOR THE DISTRIBUTED PRODUCTS. 对上市产品建立稳定性计划。

15. ORGANIZE AND MAINTAIN THE RETENTION OF RETAINED SAMPLES AS WELL AS ALL PRODUCTION, VALIDATION AND GMP RELATED DOCUMENTS. 组织并管理所有产品的留样、验证和GMP相关文件。

16. ENSURES QUALITY RISKS ARE PROPERLY MANAGED (IDENTIFICATION, ASSESSMENT, CONTROL, COMMUNICATION).

确保质量风险得到适当管理（识别、评估、控制和沟通）

17. MANAGES THE QUALITY TEAMS UNDER HIS/HER RESPONSIBILITY WITH RESPECT TO ALL APPLICABLE RULES.

按照相关的规章制度管理质量团队。

RESPONSIBLE FOR DC QUALITY ISSUE

18. RESPONSIBLE FOR BEIJING DC, DETAIL SEE ATTACHMENT PAGE.

对分销中心的质量负责，描述详见附件

19. IQC MANAGER HSE RESPONSIBILITY 质量部经理的HSE责任：

SAFETY RESPONSIBILITY: TO MANAGE AND ENSURE ALL THE IQC ACTIONS TO COMPLY WITH THE HSE POLICY AND SOP. LEAD ALL IQC STAFF TO IMPROVE CONTINUOUSLY ON THE HSE AND CONTROL WASTE. ORGANIZE TO COMPILE THE SAFETY PRODUCTION BYLAW AND THE OPERATION PROCEDURE, AND MANAGE THE IMPLEMENTATION. ENSURE THE EFFICIENCY OF THE SAFETY INVESTMENT. REVIEW THE SAFETY ISSUE PERIODICALLY. SUPERVISE THE SAFETY PRODUCTION ACTION TO ELIMINATE THE HIDDEN TROUBLE IN TIME. PASS IS THE JOB WHAT IS IN CHARGE AND THE RESPONSIBILITY FOR ALL THE MANAGERS. BE MEMBER OF THE HSE COMMITTEE TO MANAGE THE AFFECT OF THE IQC ACTIONS TO THE HSE AND THE CORRECTIVE MEASURES. BE MEMBER OF THE CRISIS MANAGEMENT. TO RESPONSIBLE FOR THE IQC EVACUATION IN CASE OF EMERGENCY. ENSURE THE MANAGEMENT OF THE DANGEROUS CHEMICAL TO COMPLY WITH THE STATE AND LOCAL RULES AND REGULATIONS.

安全责任: 负责质量部的工作，使之符合环境卫生安全政策、标准操作规程。

领导、激励部门人员在健康、安全、环境、控制废品方面不断改进。

组织制定并督促落实安全生产规章制度和操作规程；保证安全生产投入的有效实施；定期研究安全生产问题；督促、检查安全生产工作，及时消除生产安全事故隐患；PASS 是其直接管理下的工作。PASS 的制定和实施是工厂管理层的部分职责。

是工厂 HSE 管理委员会的成员，关注本部门活动的 HSE 影响，并采取措施，如发生紧急撤离是部门撤离的负责人。是危机管理小组的成员。保证危险化学品的安全管理符合有关法律、法规、规章的规定和国家标准的要求。

OH RESPONSIBILITY: TO MANAGE AND ENSURE ALL THE IQC ACTIONS TO COMPLY WITH THE HSE POLICY AND SOP. HAVE TO ADOPT VALID OCCUPATIONAL DISEASE PROTECTION FACILITIES AND PROVIDE THE PROPER PPE. CAN NOT TO ARRANGE THE EMPLOYEE WITHOUT OH INSPECTION TO BE ENGAGED IN A CONTACT POST WITH OCCUPATIONAL DISEASE. CAN NOT ARRANGE WORKER OF HAVING THE OCCUPATION TABOO TO BE ENGAGED IN IT THE WORK OF TABOO. FOR THE WORKER OF HAVING THE RELATED OCCUPATIONAL DAMAGE FOUND IN THE OH INSPECTION, SHOULD ADJUST TO LEAVE TO WORK AT FIRST POST, AND APPROPRIATE SETTING. FOR THE WORKER WITHOUT OH INSPECTION BEFORE QUITTING CAN NOT TERMINATE THE LABOR CONTACT WITH HIM.

职业健康职责: 负责质量部的工作，使之符合环境卫生安全政策、标准操作规程。

必须采用有效的职业病防护设施，并为劳动者提供个人使用的职业病防护用品。不得安排未经上岗前职业健康检查的劳动者从事接触职业病危害的作业；不得安排有职业禁忌的劳动者从事其所禁忌的作业；对在职业健康检查中发现有与所从事的职业相关的健康损害的劳动者，应当调离原工作岗位，并妥善安置；对未进行离岗前职业健康检查的劳动者不得解除或者终止与其订立的劳动合同。

ENVIRONMENT RESPONSIBILITY : THE STORE AND USE OF TOXIC CHEMICAL HAVE TO MEET THE STATE REGULATIONS TO PREVENT POLLUTION TO THE ENVIRONMENT. TAKE MEASURES TO PREVENT AND REDUCE THE SOLID AND LIQUID WASTE POLLUTION TO ENVIRONMENT.

环境职责：储存、使用有毒化学物品，必须遵守国家有关规定，放在污染环境。采取措施防止或者减少固体废物对环境的污染。

FOR SPECIFIC RESPONSIBILITY NOT COMPLETEDLY MENTIONED OR CONCERNED IN THE JOB DESCRIPTION, THE IQC MANAGER'S RESPONSIBILITY ADHERE TO APPLICABLE SOP OF THE SITE.

对于质量部经理具体职责未尽事宜，依照工厂的标准操作规程执行。

举报 分享

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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