Microbiologist 微生物师
苏州爱美津制药有限公司SuzhouUpdate time: August 28,2019
Job Description
1. Be responsible for performing microbial limit test and support the test methods transfer and validation.负责执行微生物限度测试，并支持测试方法的转移和验证。
2. Be responsible for performing the monitoring of EAS/CAS/PWS.
负责执行环境空气系统/压缩空气系统/纯水系统的监测。
3. Stability program management稳定性项目管理
- Maintain the Stability Management Chart
- 稳定性监管表。
- Ensure the correction of the launch and termination of the stability project and schedule the sampling plan.
确保稳定性项目开启和终止的正确性，并制定取样计划。
4. Assist sampling activities of Raw Materials and Stability Samples.
协助进行原辅料和稳定性样品的取样。
5. Participate in 6S work in lab and maintain the cleanliness of test area.
参与实验室6S工作，维持实验室的清洁。
6. Participate in Microbial OOT/OOS investigation and evaluation.
参与微生物相关的超标调查和评估。
7. Other tasks assigned by superior.其他上级安排的工作。
岗位要求：
1. Bachelor or above degree. 本科或以上学历。
2. Major in Microbiological or related. 微生物或相关专业。
3. 1 year's related experience in Pharmaceutical industry. 1年以上制药企业相关经验。
4. cGMP knowledge for microbiology lab in the pharmaceutical industry.药品行业微生物实验室cGMP相关知识。
5. Excellent skill in pharmaceutical microbial limit test method. 熟练掌握制药工业微生物限度测试方法。
6. Good English. 良好的英语能力。
职能类别： 生物工程/生物制药
微信
联系方式
上班地址：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
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
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