招聘人数:1-2人
到岗时间:不限
年龄要求:不限
婚况要求:婚姻状况
Main Tasks & Responsibilities主要工作职责:
Documentation control
1.Create, update and distribute of QC SOPs, test instructions and test specs including verify the Chinese translation for the documents transferred from other sites
2.Submit work flow for document approval in DiaDoc (Document management system)
3.Coordinate the SOP periodic review
4. Archive quality records such as batch records, validation records etc.
Batch record review
1.Review QC batch record (DHR) for the batch information, testing result etc
2.Release the batch at QC stage
3. Trend the batch review results
Training coordination
1.Coordinate the implementation of trainings
2.Support the establishment of the training matrix/plan
3.Maintain training plan and training record
Data analysis
1.Monitor and trend product performance
2.Collect KPI(key performance indicators) data in a certain frequency
IT Related
1.Coordinate the access application for e-systems such as SAP, DiaDoc etc.
Education&Qualifications教育背景与专业资格:
Bachelor Degree in Business or Engineering or Science
Experience工作经验:
1. More than 5 years’ experience in the required functional area
2. Experience in ISO 13485 environment is preferred
Language skills
Native or fluent Chinese
Fluent English
Professional Competencies/skills专业能力/技能:
1. Diligent with attention to detail
2. Collaborates well
3. Dynamic and vigorous
4. Self-motivated & self-sufficient
5. Team player with the ability to work on their own initiative
6. A can-do attitude and willingness to go the extra mile when required
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