西安招聘

职位描述：
Essential duties and responsibilities:
1.贯彻实施JNJ各项标准（如：质量协议、采购控制、温度控制、再包装等）
Perform JNJ standard as enterprise strategy including quality agreement, purchasing control, temperature control, repack/relabeling.
2.第三方物流监管（监督指导第三方物流质量验收、养护、存储，定期进行质量审计,包括CLS的3PL）；
Supervise 3PL operation (direct 3PL GR/maintenance/storage/dispatch, conduct 3PL audit on regular);
3.GSP质量文件体系维护（起草/变更/审核，指导、督促制度执行）；
Maintain GSP quality management system (Draft/revise/review relevant SOP according to regulations and group requirements, and supervise the implementation of SOP);
4.制定GSP内审计划方案并实施；
Make GSP internal audit plan and schedule; perform the audit with relevant department;
5.指导设定计算机系统质量控制功能，并在实际运作中进行监督、审核和控制；
Conduct the quality control function of computerized system, and monitor/review/control during actual operation in computerized system;
6.按照国家法规及JNJ集团规定处理假劣药品报告、不良反应报告、召回事件；
Responsible for handling fake drug report / AE report / recall affair according to regulations and JNJ standard.
7.负责首营企业、首营品种及销售客户的审批工作，并且建立和维护相关质量档案；
Review supplier/new product/customer’s certificates, create and maintain these quality document;
8.负责药品质量的查询和药品质量事故或质量投诉的调查、处理及报告;
Investigate/handle/report the quality inquiry, complaint and accident;
9.收集、汇总和分析药品质量信息以及相关的政策和法规，必要时进行差异分析;
Collect and analyze the regulatory or quality related requirement, trends and latest changes; perform GAP assessment if necessary;
10.承担产品放行的职责，确保每批已放行产品的符合相关法规要求；
Responsible for product release and to ensure that the production in accordance with the related regulations requirements;
11.协助开展质量管理教育和培训；
Participate in conducting GSP and quality management training;
12.上级主管交付的其它工作。
As per other assignments by direct supervisor if necessary.


   Essential knowledge and skills:
1.教育背景Education Background
药学或相关学科本科或以上学历。
Bachelor degree or above preferred on Pharmacy or other relevant science.
2.执业资格 Qualification
执业药师，上海药品经营企业质量负责人上岗证
Licensed pharmacist/ Quality lead certificate of Shanghai drug distributors
3.工作经验Working Experience
至少5年以上药品经营质量管理经验。
At least 5 years’ experience in drug distribution quality management
4.领导力及相关技能Leadership skills
注重客户需求，以结果和绩效为导向，具备前瞻和危机意识；
Customer Focus（Results and Performance Driven，Sense of Urgency）；
进取心强，处事谨慎；
Intellectual Curiosity，Prudent Risk-Taking
擅于团队合作，适应性强。
Collaboration, Teaming and Adaptability.
5.良好的沟通技巧
Good communication skill
6.英语四级CET4
7.熟练操作各办公应用软件
Good knowledge of Computerized Software
8.良好的工作汇报技巧
Good presentation skills
9.具备良好的GMP/GDP/GSP/GWP， ISO,质量体系及指导的知识
Strong knowledge of GMP/GDP/GWP/GSP, ISO, quality systems and guidelines of cross sectors.
10.本地法规
Local RA requirement
11.审计技能
Audit Skill 举报 分享

拥有125年历史的美国强生公司是世界上最具综合性、业务分布范围最广泛的健康护理产品的制造和服务企业，为消费品、制药以及医疗器材和诊断产品市场提供全面的产品和服务。强生公司连续多年名列《财富》“全球最受尊敬的公司”排行榜前列。
 
强生公司一致注重在中国的发展，强生（中国）有限公司1992年在上海市闵行经济技术开发区成立，是强生公司在中国大陆设立的首家独资企业，致力于生产和推广高品质的适合各种年龄段的个人卫生护理用品，推动中国家庭健康护理水平的提高，公司的产品不仅供应国内消费品市场，而且还出口供应国际市场。强生（中国）有限公司的使命是成为中国最受信赖的消费类健康保健公司。公司致力于生产和销售高品质的个人保健产品，以增进中国家庭的健康。
 
With more than 100 years of history, Johnson & Johnson (JNJ) is the world’s most broadly based healthcare company discovering, developing, and manufacturing consumer health, pharmaceuticals, and medical devices and diagnostics products. With over 250 operating companies, Johnson & Johnson has approximately 114,000 employees in 57 countries and markets its products throughout the world. It has been ranked among the top of the global Most Admired Companies by Fortune for years.
Johnson & Johnson has been committed to its development in China. Established in Shanghai Minhang Economic & Technological Development Zone in January 1992, Johnson & Johnson China Ltd. is the first wholly-funded enterprise set up by Johnson & Johnson. It is committed to producing and promoting high quality personal health care products catering for consumers of various ages, and driving the health care of Chinese families. Its products are not only sold in domestic consumer market, but also exported to international markets. The mission of Johnson & Johnson China Ltd. is to become the most reliable consumer health care product provider in China. It is committed to producing and selling high quality health care products to enhance the health of Chinese families.
 
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