组件区高级生产主管 (职位编号：93795526)
天津百特医疗用品有限公司
- 公司规模：500-1000人
- 公司性质：外资(欧美)
- 公司行业：医疗设备/器械
职位信息
- 发布日期：2021-01-11
- 工作地点：天津-北辰区
- 招聘人数：1人
- 工作经验：5-7年经验
- 学历要求：本科
- 职位类别：药品生产/质量管理
职位描述
Responsibility
- Establish the component production processes and procedure according to the cGMP requirement and Baxter requirement.
- As the key player to complete all the validation activities during the project phase and daily operation according to cGMP requirement and Baxter quality system.
- Participate and present documents/process at inspections of authorities, ensure to pass the SFDA and other inspections related with component production.
- Handle the non-conformity and CR cases for the validation and daily operation.
- Training of future employees, e.g. operators, technicians and engineers.
- Capable of operating the equipment and other operational procedure of validation and test phase.
- Ensure overall product quality in the component production area; and ensure good cGMP understanding and Quality Mindset on production teams.
- Use the LEAN tools to improve the current process and operation, ensure that the component production provides cost-effective and high quality product timely and efficiently.
- Assist to production manager to manage production team to make sure all activities during the production shift comply with SOP, GMP, EHS and other regulatory requirements.
- Assist dept. manager to achieve the KPIs and VIP project.
- Understand and implement Baxter, division and regulatory EHS requirements as applicable to process engineer, report incidents of noncompliance with EHS laws and requirements or failure to carry out EHS responsibilities, which endanger the environment or people.
Requirements
- At least a bachelor in Pharmacy or Engineering.
- More than 5 years of production experience in a manufacturing environment preferably in the pharmaceutical, medical or similar industry.
-Familiar with the processes of pharmaceutical manufacturing and GMP management.
- Good oral and written English level.
- Have good leadership and communication skills.
- Establish the component production processes and procedure according to the cGMP requirement and Baxter requirement.
- As the key player to complete all the validation activities during the project phase and daily operation according to cGMP requirement and Baxter quality system.
- Participate and present documents/process at inspections of authorities, ensure to pass the SFDA and other inspections related with component production.
- Handle the non-conformity and CR cases for the validation and daily operation.
- Training of future employees, e.g. operators, technicians and engineers.
- Capable of operating the equipment and other operational procedure of validation and test phase.
- Ensure overall product quality in the component production area; and ensure good cGMP understanding and Quality Mindset on production teams.
- Use the LEAN tools to improve the current process and operation, ensure that the component production provides cost-effective and high quality product timely and efficiently.
- Assist to production manager to manage production team to make sure all activities during the production shift comply with SOP, GMP, EHS and other regulatory requirements.
- Assist dept. manager to achieve the KPIs and VIP project.
- Understand and implement Baxter, division and regulatory EHS requirements as applicable to process engineer, report incidents of noncompliance with EHS laws and requirements or failure to carry out EHS responsibilities, which endanger the environment or people.
Requirements
- At least a bachelor in Pharmacy or Engineering.
- More than 5 years of production experience in a manufacturing environment preferably in the pharmaceutical, medical or similar industry.
-Familiar with the processes of pharmaceutical manufacturing and GMP management.
- Good oral and written English level.
- Have good leadership and communication skills.
职能类别：药品生产/质量管理
公司介绍
百特是全球领先的医疗用品公司，百特专注于危重治疗领域，在肾科、药物输注和生物科技等领域通过提供先进的多样化的产品和服务。
百特总部设在美国芝加哥，是***进入中国医疗市场的大型跨国公司之一，目前已在中国多个城市建立了办事处，并建立了五家大规模的合资和独资生产企业，一家研发中心。
天津百特医疗用品有限公司于1995年成立，占地面积10,496平米，其中实验室2,400平方米，500余名员工。目前主要产品是以葡萄糖、氯化钠为代表的大输液产品。
未来两年内，百特天津工厂将投产肾科相关腹膜透析产品，目前正在进行项目建设中，诚邀各方英才的加入！
百特总部设在美国芝加哥，是***进入中国医疗市场的大型跨国公司之一，目前已在中国多个城市建立了办事处，并建立了五家大规模的合资和独资生产企业，一家研发中心。
天津百特医疗用品有限公司于1995年成立，占地面积10,496平米，其中实验室2,400平方米，500余名员工。目前主要产品是以葡萄糖、氯化钠为代表的大输液产品。
未来两年内，百特天津工厂将投产肾科相关腹膜透析产品，目前正在进行项目建设中，诚邀各方英才的加入！
联系方式
- Email：TTA@baxter.com
- 公司地址：百特天津工厂