质量工程师(文控及合规
百特(中国)投资有限公司
- 公司规模:500-1000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2020-10-22
- 工作地点:上海-金山区
- 招聘人数:1人
- 工作经验:在校生/应届生
- 学历要求:本科
- 语言要求:英语良好
- 职位月薪:1-1.5万/月
- 职位类别:医疗器械生产/质量管理
职位描述
1. Responsible for quality system audit and optimizations. 负责内外部质量体系审核,推动工厂质量体系的持续改善和有效实施;
2. GMP regulatory tracking, compliance implementation and ensure no GMP gaps for plant operation. 组织法规文件的跟踪,确保GMP/质量相关法规在工厂得到有效建立和实施;
3. Maintain GMP related license/certificate. 负责药品生产相关证书有效性的维护(如:GMP证、生产许可证、OEM证等);
4. Maintain and coordinate quality related SOP system. 维护和协调质量相关的SOP系统。
5. Support supervisor/manager for management review implementation. 支持实施管理评审。
6. Support the budget of Document Center. 支持文件中心预算工作。
7. Responsible for GMP and GDP training. 负责管理工厂GMP及GDP相关的培训;
8. Responsible for annual product review 完成产品年度质量回顾
9. Coordinate quality management report and data collection draft完成部门质量管理及质量数据报告编写
10. Coordinate GMP related cross function communication, and meet EHS requirements.协调GMP相关的跨部门合作;在部门工作中遵守环保、健康与安全的法规要求。
11. Supervisor/manager’s assignment. 完成上级安排的其他工作。
任职要求:
1. Fluently English written, spoken and reading. 流利的英文书写与阅读能力
2. Logical thinking and problem solving. 思考解决问题的能力
3. Effective communication. 有效的沟通
4. Team work to drive the result. 团队协作的能力
5. GMP operation knowledge. GMP知识
6. Familiar with quality system inspection. 熟悉质量系统审核。
职能类别:医疗器械生产/质量管理
公司介绍
Baxter International Inc. provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s 50,000 employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
联系方式
- Email:TTA@baxter.com
- 公司地址:杭州