知名医药医疗器械公司 SQE工程师
万宝盛华企业管理咨询(上海)有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:中介服务
职位信息
- 发布日期:2021-01-12
- 工作地点:上海-浦东新区
- 招聘人数:若干人
- 工作经验:3-4年经验
- 学历要求:大专
- 语言要求:英语
- 职位月薪:0.8-1万/月
- 职位类别:医疗器械研发 医疗器械生产/质量管理
职位描述
RESPONSIBILITIES
1. Identify applicable requirements from GxP regulations, industry standards, policies from AQR/ARDx/BU with support from SME.
2. Understand the improvement opportunities for SPDS workstream, evaluate the risk of improvement opportunities and provide professional improvement advice to the company.
3. Provide support to SPDS workstream remediation planning, execute the activities in accordance with plan and report out the deliverables and exception.
4. Look back SPDS records, remediate it and document the result.
5. Update applicable SOPs if necessary.
6. Provide professional support and trainings to stakeholders where necessary.
7. Drive the SPDS process improvement program if necessary.
8. Track and measure the implementation of SPDS remediation actions.
9. Join the meeting, conference call and summarize the report etc.
10. Undertake other tasks that assigned by superior.
REQUIREMENTS
? 文化程度 Education:
Collee degree or above.
? 任职经验 Working Experience:
1.3 years or above experience, preference in pharmaceutical, medical device, IVD or healthcare industries.
? 专业知识/技能 Professional Knowledge/Skill :
1. Familiar with GMP, ISO13485, ISO14971, 21CFR Part 820 related regulatory requirements and guidelines.
2. Familiar with 21 CFR part 11, data integrity.
? 计算机及外语水平 Computer & Language Skill:
1. Good command of English
2. Good computer and MS software skills.
3. Good skills of writing, presentation skills.
? 能力要求 Competency:
1. Self-disciplined, self-motivated and with good working ethic.
2. Good teamwork and communication/coordinating skills, be able to coordinate related work properly.
职能类别:医疗器械研发医疗器械生产/质量管理
公司介绍
联系方式
- Email:manpowerrecruiting@163.com
- 公司地址:华苑产业园海泰大道