苏州招聘

职位描述：
1. Manage, coach and develop the QA inspection team, to make sure all activities perfomed in compliance with relevant GMP and Quality Sytstem standards and specifically with FDA Quality System Regulation and China GMP.
管理，带教和发展QA在线检验团队，确保所有的活动符合相关GMP和质量体系标准要求，特别是FDA和中国GMP的法规要求。
2. Review batch manufacturing record documentation for completeness, accuracy and cGMP compliance. Sampling and release raw materials, packaging materials, intermediates and finished products.
复核生产记录文件以保证完整、准确并符合cGMP规定。取样并放行原料，包材，中间体和成品。
3. Work closely with manufacturing team to identify potential issues form production line and take CAPA to ensure product quality and process capability.
和生产部紧密合作，及时发现产线上可能的问题，并采取更正预防措施确保产品质量和工艺能力。
4. Support internal audit and supplier audit
支持公司内审及供应商审核。
5. Conduct periodic product quality review and trend analysis for finished products. Product quality and performance programme management with data and report assessment for continuous improvement.
对产品质量进行定期回顾和趋势分析，评估数据和报告，提出持续改进机会。
6. Assist management in Performing/Participating in deviation/investigation report of manufacturing and/or Manufacturing Support issues.
协助管理层实施在生产或生产支持事务的偏差/差异调查。
7. Track and manage relevant quality system documentation to keep it up-to-date.
追踪并管理相关质量体系文件确保文件及时更新。
8. Other related duties as assigned by supervisor.
其他上级主管指派的相关工作。

职位要求：
1. Bachelor or above on Chemistry or pharmaceutical related major or experience.
本科以上，化学、制药相关专业。
2. 6+ years in a quality environment with 3 or more years in a people management role.
6年以上质量相关经验，3年或以上人员管理经验。
3. Knowledge of US FDA cGMP and CFDA GMP manufacturing regulations for pharmaceutical products.
药品生产US FDA cGMP和中国CFDA GMP法规知识 。
4. Detailed Documentation and Organization Skills.
细致的文件和组织能力。
5. Good read and understand / write in English.
良好的英语读写和理解能力。
6. Familiar with Microsoft Office.
熟悉使用微软office软件。
7. Good communicating skills and leadership.
良好的沟通及领导能力。 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