苏州招聘

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 anlaytical 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 举报 分享

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