validation engineer 验证工程师 (灭菌类产品)
麦朗(上海)医疗器材贸易有限公司
- 公司规模:150-500人
- 公司性质:外资(欧美)
- 公司行业:医疗/护理/卫生
职位信息
- 发布日期:2021-01-14
- 工作地点:武汉-武昌区
- 招聘人数:1人
- 工作经验:2年经验
- 学历要求:本科
- 语言要求:英语精通
- 职位类别:医疗器械生产/质量管理 医药技术研发管理人员
职位描述
Job Responsibility
1 Work as project manager for validation/qualifications in order to approve purchasing sterile medical products from suppliers/manufacturers in Asia
2 Prepare study protocol and report in English
3 Supervise and train plant personnel for performance of technical studies and procedures
4 Write technical agreements with suppliers
5 Perform technical and regulatory audits of sterilization facilities and medical device manufacturers.
6 Intensive travels to vendors for quality check and ensure suppliers meeting quality requirements
Requirement
1 Bachelor degree or above, major in Biotechnology, Pharmaceutical, Chemical or Engineering
2 1-2 years of work experience in quality/technical department of health care related company. Experience in validation/qualification activity is an advantage.
3 Knowledge of GMP regulation, AAMI and ISO standards and validation methods is preferred.
4 Microsoft Word and Excel experience at an intermediate level is required
5 Fluently in both oral and written English
6 Willing to travel intensively
7 Project management skill is a plus
公司介绍
Our Website: https://medlineasia.com.cn/
联系方式
- Email:hrchina@medline.com
- 公司地址:建设大道588号卓尔国际中心