Equipment Technician/Engineer 设备技术员/工程师
苏州爱美津制药有限公司
- 公司规模:50-150人
- 公司性质:外资(非欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2016-12-08
- 工作地点:苏州-工业园区
- 招聘人数:1
- 学历要求:大专
- 职位月薪:面议
- 职位类别:医疗器械维修人员
职位描述
Requirements:
1. Diploma or Bachelor in Pharmaceutical or chemical industry mechanics.制药或化工机械专业,大专/本科。
2. At least 3 years Pharmaceutical or chemical industry equipment management experience.至少3年制药或化工设备管理经验
3.Know some tablet and capsule production equipment, like: Fluid Bed Dryer, High Shear Granulator, Blender, Tablet Press, Coater, Blister Packing and Packaging Line.
了解一些片剂和胶囊的生产设备,如:流化床,高位湿法制粒机,搅拌机,压片机,包衣机,泡罩包装和包装生产线。
4. Have both mechanical and electrical knowledge and can solve problem independently
有机械和电力知识,能独立解决这类问题
5. Have GMP and clean room working experience
有GMP和洁净室的工作经验
Main responsibilities:
1.Solve mechanical and electrical problem of the production equipment timely.
及时解决生产设备的机械和电力问题
2.Implement production equipment PM work on time and improve PM system to reduce unplanned breakdown time to the minimum.按时实施生产设备的预防性维护工作,改进预防性维护系统,将意外故障时间降低到最少。
3.Take part in production equipment installation, commissioning, validation and improvement. 参与生产设备的安装,调试,验证和改进
4.Complete maintenance log and other documents to meet GMP requirement.
填写维护日志以及其他一些GMP要求的文档
1. Diploma or Bachelor in Pharmaceutical or chemical industry mechanics.制药或化工机械专业,大专/本科。
2. At least 3 years Pharmaceutical or chemical industry equipment management experience.至少3年制药或化工设备管理经验
3.Know some tablet and capsule production equipment, like: Fluid Bed Dryer, High Shear Granulator, Blender, Tablet Press, Coater, Blister Packing and Packaging Line.
了解一些片剂和胶囊的生产设备,如:流化床,高位湿法制粒机,搅拌机,压片机,包衣机,泡罩包装和包装生产线。
4. Have both mechanical and electrical knowledge and can solve problem independently
有机械和电力知识,能独立解决这类问题
5. Have GMP and clean room working experience
有GMP和洁净室的工作经验
Main responsibilities:
1.Solve mechanical and electrical problem of the production equipment timely.
及时解决生产设备的机械和电力问题
2.Implement production equipment PM work on time and improve PM system to reduce unplanned breakdown time to the minimum.按时实施生产设备的预防性维护工作,改进预防性维护系统,将意外故障时间降低到最少。
3.Take part in production equipment installation, commissioning, validation and improvement. 参与生产设备的安装,调试,验证和改进
4.Complete maintenance log and other documents to meet GMP requirement.
填写维护日志以及其他一些GMP要求的文档
公司介绍
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
联系方式
- Email:hr@amerigenpharma.com
- 公司地址:上班地址:苏州工业园区群星一路58号