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5-7年经验 -
本科 -
招2人 -
11-09 发布
职位描述
职位描述： 1.Work independently, complete sample test within the stipulated time and with compliance to cGMP and standard operating procedures, quality standards and test methods.独立工作，在规定的时间里完成样品测试并且符合cGMP和标准操作规范、质量标准和测试方法。2.Ensure the integrity and accuracy of data, records, and results, and take responsibility for the test results;确保数据、记录和结果完整、真实，并对测试结果负责。3.Conduct the qualification, calibration and maintenance of the instrument/equipment in Chemical Lab under supervision; 进行化学实验室仪器/设备的确认、计量和维护。4.Contribute ideas, solutions, and knowledge to support the technical growth of the department and company;贡献想法、解决方案和知识来支持部门和公司的技术成长。5.Participate in training and self-development activities; 参与培训和自我发展的活动6.Follow and support all EH&S policies, practices and procedures. 遵从和支持所有EHS的政策、规范和流程Requirements要求：1. Good English Skill （CET-4 or above) 良好的英语技能2. Good Knowledge of analytical instrument. 良好的分析仪器知识3. Good awareness on cGMP/GMP regulation. 良好的cGMP/GMP意识4. Over 5 years in chemical lab in pharma industry. 5年及以上化学实验室制药行业工作经验 职能类别： 化学分析测试员
联系方式
苏州工业园区群星一路58号
公司信息
Amerigen Pharmaceuticals is a multinational company with established development and manufacturing platforms aimed at providing high-quality generic pharmaceutical products. Its headquarter is based at New Jersey, US. 爱美津制药是一家集研发和制造于一体的跨国公司，旨在向美国提供高质量的仿制药品。总部位于美国新泽西州。 With pharmaceutical assets and science-based expertise in the United States and abroad, Amerigen is able to provide quality products at competitive prices along with unmatched customer service. 凭借在美国和海外的制药资产和技术专家队伍，爱美津致力于提供高品质产品、有竞争力的价格和无以匹敌的客户服务。 At the end of 2007, Amerigen has successfully completed the acquisition of an oral solid dose manufacturing facility in Suzhou Industrial Park, China and established Suzhou Amerigen Pharmaceutical Co., Ltd. 2007年底，爱美津完成了在中国苏州工业园区的口服固体制剂生产厂的收购，并成立了苏州爱美津制药有限公司。 The milestones of Suzhou Amerigen are as follows: 苏州爱美津制药的里程碑如下： 2007 Suzhou Amerigen was established 苏州爱美津成立 2008 First US regulatory filing 首次获得美国法规文件受理 2009 First US FDA PAI & General Inspection 首次美国食品药品监督管理局上市批准和常规检查 2010 Received US FDA approval for bulk tablet manufacturing 获得美国食品药品监督管理局的批准生产大包装片剂 2012 Passed CFDA Re-Inspection (GMP 2010 version) 通过中国食品药品监督管理局再次检查-新版GMP (2010版) 2013 Passed US FDA Inspection –Recommended approvals on four ANDAs 通过美国食品药品监督管理局检查- 4个简化新药被推荐批准 2014 Launched US Product and re-introduced China Products 产品在美国市场上市, 中国市场产品恢复生产。 2015 Passed US FDA Inspection on Data Integrity 通过美国食品药品监督管理局针对数据完整性的专项检查
