北京招聘

工作职责 Responsibilities:

负责OTC产品开发项目的分析方法开发和验证, 撰写分析方法验证方案,报告及分析方法;
Responsible for analytical method development, validation and transfer for OTC NPD projects；technical writing include method validation protocol, report and test method;

根据稳定性研究实验方案开展稳定性实验考查,参与OOS/OOT的调查；
Conduct stability testing per stability study protocol, involve in OOS/OOT investigation;

负责原料药及辅料和产品质量标准的建立，及供应商资质和产品质量的考察；
Responsible for establishing specifications for API, excipients and finished product, and participate qualifying the vendors and products if necessary;

参与原辅料及成品的微生物检测方法和质量标准的建立， 协调内部外部方法验证及转移的事项；
Responsible for Microbial test methods and specification for raw materials and finished product, coordinate the method validation and transfer activities among R&D, QC and third party lab;

负责新药注册申报资料分析研究部分的撰写，并为现场核查和与新药注册相关事宜提供技术支持；
Responsible for the analytical research data/section of regulatory CTD dossier for new drug registration, and provide technical support for on-site inspection and registration related activities;

对分析方法从研发中心转移到生产厂提供必要的支持，协助工厂解决技术上难题,以支持新产品和上市产品满足质量和合规的需要;
Provide necessary supports for technical transfers from R&D to manufacturing sites, troubleshoot for analytical issues to support new product and marketed product fully meeting the requirement of quality and compliance;

参与与相关部门的技术讨论, 与亚洲分析中心，美国研发中心和合同实验室保持紧密的沟通和合作；
Join the technical discussion with business partners, cooperate closely with AP Technical Centre, US R&D centers and contract labs;



任职要求 Requirements:

本科或以上学历，药物分析或分析化学相关专业,硕士优先考虑。
Bachelor degree or above, Pharmaceutical Analysis or Analytical Chemistry related, Master degree preferred

有3-5年以上化药分析方法开发经验,熟悉GMP工作环境。有微生物检测经验优先考虑。
3 – 5 years of pharmaceutical analytical development experi-ence, working under GMP environment. Experience/knowledge with microbiology as an asset.

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.
 
更多机会请登陆www.careers.jnj.com

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