天津 [切换城市] 天津招聘天津生物/制药/医疗器械招聘天津药品生产/质量管理招聘

QE主管 (职位编号:73695526)

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

The position is responsible for establishing and maintaining production process to comply GMP, regulatory requirements, keeping operation in meeting ISO9000,GMP and Baxter standards by continuous improvement.

Responsibility

- Design, maintain and improve the NCR Management system in line with the regulation, and ensuring the procedures are in place within the Baxter management system.

- Lead Non-conformance investigation to ensure process is complied with SOP, and make correct judgment for the impact products.

- Lead and guide activities of IPC team for medicine and medical device, to ensure processes are complied with SOPs and ensure in-process control on time.

- Rectifying or reporting on any deviations from GMP or QMS.

- Coordinate, assess, investigate and approve product/process quality investigation and assure appropriate corrective and preventive actions are implemented.

- Provide GMP advice to production area, act as quality coach and mentor to value streams through alignment proactive involvement in quality improvement and inspection readiness activities and focusing on prevention activities in support of achieving business objectives.

- Approve all quality related systems, procedures and documentation utilized within plants.

- Deliver GMP and QMS training.

- Responsible for QE team development, improve team engagement.

- Understand and implement Baxter, division and regulatory EHS requirements as applicable to this position.

- Other tasks authorized by Quality Manager.

Requirements

-  At least a bachelor degree in pharmaceutical, medical or chemical.

- Quality management experiences in medical manufacture international company for more than three years and be familiar with production on-site management.

- Strong sense of responsibility and principle.

- Good skills on English and computer.

- Good leadership and human relationship skills.

职能类别:药品生产/质量管理

关键字:QE

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!

联系方式

  • Email:TTA@baxter.com
  • 公司地址:百特天津工厂