南平招聘

职务描述
The role is responsible for batch document reviewed timely, perform QA oversight in Production, and assure that products’ production activities complies with Sanofi Quality Policy and GMP requirement.
Major accountabilities:
Review batch document and records timely and ensure that following requirements have been met:

All the necessary checks and tests have been performed.
Review QC testing record and ensure the report had been approved by qualified personnel and the product quality confirms to specifications.
All necessary production documentation has been completed and endorsed by qualified personnel and are in compliance with Sanofi quality policy, local regulatory and GMP requirements.
The manufacturing and marketing authorization requirements for the product have been met for each released batch.
The principles and guidelines of GMP, as laid down in the guidelines published by HA, have been followed
The change for critical parameters for manufacturing and testing processes have been validated
Any changes or deviations in manufacturing or quality control have been notified and evaluated in accordance with a well-defined system before any products is released
All relevant factors have been considered, including any abnormalities which is not directly related to product when review batch document
Provide basic training for production operators to support the batch RFT improvement
Lead deviation investigation in QA, reviews deviation report and ensure deviation investigation was performed following the procedure and meet with GMP requirement and will be completed timely. Lead product quality review and ensure the PQR is completed following the procedure and GMP requirement timely. GMP monitoring, perform the oversight review as shift QA, escalate timely and promote or follow up the complete of related actions. Complete individual training according to individual annual training plan, and other training Complete CAPA timely triggered by deviation, internal or external audit. Provide effective compliance supporting and services to others Complete other work assigned by the superior.
Major accountabilities 主要职责:
Review batch document and records timely and ensure that following requirements have been met及时审核批次文件并记录，并确保满足以下要求：
All the necessary checks and tests have been performed. 已完成所有必要的检查和测试。
Review QC testing record and ensure the report had been approved by qualified personnel and the product quality confirms to specifications. 检查质量控制测试记录并确保报告已经过合格人员的批准，产品质量符合规范。
All necessary production documentation has been completed and endorsed by qualified personnel and are in compliance with Sanofi quality policy, local regulatory and GMP requirements. 所有必要的生产文件均已由合格人员完成并认可，并符合赛诺菲质量政策，当地法规和GMP要求。
The manufacturing and marketing authorization requirements for the product have been met for each released batch. 每个已发布的批次都符合产品的制造和销售授权要求。
The principles and guidelines of GMP, as laid down in the guidelines published by HA, have been followed. 已遵循医管局发布的指引所载的GMP原则和指引。
The change for critical parameters for manufacturing and testing processes have been validated. 已经验证了制造和测试过程的关键参数的变化。
Any changes or deviations in manufacturing or quality control have been notified and evaluated in accordance with a well-defined system before any products is released. 在任何产品发布之前，已根据明确定义的系统通知和评估制造或质量控制方面的任何变更或偏差
All relevant factors have been considered, including any abnormalities which is not directly related to product when review batch document. 已经考虑了所有相关因素，包括在审核批处理文件时与产品没有直接关系的任何异常情况。
Provide basic training for production operators to support the batch RFT improvement. 为生产操作员提供基本培训，以支持批量RFT改进。
Lead deviation investigation in QA, reviews deviation report and ensure deviation investigation was performed following the procedure and meet with GMP requirement and will be completed timely. 负责偏差调查，审核偏差报告，确保按照程序进行偏差调查，符合GMP要求，并及时完成调查。 Lead product quality review and ensure the PQR is completed following the procedure and GMP requirement timely. 主导产品质量审核，确保PQR按照程序和GMP要求及时完成 GMP monitoring, perform the oversight review as shift QA, escalate timely and promote or follow up the complete of related actions. GMP监控，作为QA进行监督审查，及时升级并促进或跟进相关行动的完成。 Complete individual training according to individual annual training plan, and other training根据个人年度培训计划和其他培训完成个人培训 Complete CAPA timely triggered by deviation, internal or external audit. 通过偏离，内部或外部审计及时触发完成CAPA Provide effective compliance supporting and services to others为他人提供有效的合规支持和服务 Keep on developing the sops according the global quality standard/cGMP and other local requirements with other departments.
根据全球质量标准、现行GMP及其他国内要求，配合其它部门对标准操作规程进行不断改进升级
Complete other work assigned by the superior. 完成上级指派的其他工作 质量部HSE职责：
? 负责贯彻公司HSE的有关规定，把公司HSE制度的措施贯彻到每个具体环节。
? 将HSE工作纳入工作计划中。
? 组织实施本部门HSE管理目标计划，落实HSE规章制度、HSE操作规程和HSE技术措施计划。
? 定期开展本部门HSE隐患排查治理工作，制定整改计划并按时完成隐患整改。
? 负责部门级HSE教育与考核工作；及时处理员工提出的意见。
? 积极配合HSE管理工作，防止各类事故的发生。
? 定期开展本部门各级+QDCI会议，结合HSE8要求，及时、正确填写和反馈各类HSE问题，并积极落实整改。
? 参加事故调查分析工作，从质量管理角度分析事故原因，提出事故防范措施。
? 负责制定年度部门PASS计划，并按进度组织实施。
Sanofi (Beijing) Pharmaceutical Co., Ltd. Energy Policy: "Quality as the top priority, through technical, behavioral, human consciousness, continuously reduce the rate of energy consumption in product value, benefit the users, and promote company development". Good awareness of energy conservation is required, participate in energy saving actions, and assist in the continuous development of the energy management system.
赛诺菲（北京）制药有限公司能源方针：“以药品质量为第一要务，通过技术手段，行为规范，人为意识，不断降低产品价值中的能耗比重，造福广大用户，促进企业发展”要求每位员工具有良好的节能意识，积极的节能行动，协助能源管理体系的持续开展
? Actively propose energy-saving projects
积极提出节能方案
? Support the development of energy-saving projects and give positive feedback
支持节能项目的制定，积极反馈意见
? Participate in and implement energy-saving projects
参与并实施节能项目
? Participate in internal audit of energy management system
参与能源管理体系的内部评审
职位要求：
Education / experience
?A bachelor degree in pharmacy or similar disciplines.
药学或相关专业本科。
?At least 1 years related experience in drug quality control and /or quality assurance.
1年以上生产质量管理相关工作经验。
Technical skills &Competencies / Language
?Must be a committed "quality" professional with knowledge of regulated quality systems within the pharmaceutical or related industry.
具备药学或相关工业领域质量系统相关专业知识。
?Knowledge of Chinese pharmaceutical rules is mandatory as well as basic knowledge of international GMP’s.
须具有中国药品管理知识及国际GMP的基本知识。
?Good command of written and spoken English
具备良好的英语书写和表达水平。
?Good communication skills
良好的沟通能力
?Able to burden pressure
能够耐受压力。

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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