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藥明康德新藥開發有限公司

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 藥明康德新藥開發有限公司
 GLP-QA專員
職位類型: 研究開發類 薪金待遇: 面議
招聘部門: 招聘人數: 人數不限
發布日期: 2019-9-24 截止日期: 2020-12-31
工作地區: 上海 現所在地: 不限
學歷要求: 本科 工作年限: 一年以上
年齡要求: 不限 性別要求: 不限

職位描述:
Responsibilites:
1. Responsible for ensuring Quality improvement plan is developed, implemented, monitored and modified as needed.
2. To coordinate employee training, prepare annually training summary and new year training plan.
3. Responsible for employee files maintaining, include job description and CV updating.
4. Training material maintenance.
5. SOPs coordinate for sure distribution, recall and destroy timely.
6. Study folder maintenance, for sure the study folder updating, distribution and recall in control.
7. Assist the quarterly site self assessment.
8. Participant in study audit, include protocol review, phase audit and report audit.,etc.
9. Maintain QAU filing system
10. Participant in findings sharing material preparing.
11. Collecting the quality information timely, assist QA management to enhance GLP quality system.

Qualification:
1. Must have experience in GLP or GMP Quality Assurance.
2. Must be trained in or have experience with the requirements of the SFDA, FDA GLP regulations and OECD GLP guidelines
3. BS, MS OR Ph.D. degree in a science discipline with experience or training in Chemistry, pharmaceutical, or equivalent experience
4. Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.
5. Must be able to openly share information and work in a team-oriented manner in order to accomplish performance objectives.

  
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