Wangfei Sun
GLP QA at 上海药明康德新药开发有限公司- Claim this Profile
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英语 Professional working proficiency
Topline Score
Bio
Credentials
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稻壳儿设计师
稻壳儿May, 2019- Nov, 2024
Experience
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上海药明康德新药开发有限公司
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China
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Pharmaceutical Manufacturing
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1 - 100 Employee
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GLP QA
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Aug 2020 - Present
1. Review based on research projects, including plan review, critical experimental review, data review (test logbook), report review, and report confirmation review, etc.: 2021.01.01-up to now, an average of about 50 projects have been undertaken, and a total of 150+ QA audit reports have been issued Copies, first in the department 2. Participate in vendor evaluation, risk assessment and audit 3. Manage and supervise the implementation of quality training plans and training assessment of various departments 4. Conduct institutional review, special review, computerized system review, SOP review, and communicate with various departments 5. Assist and recommend QA management to improve the quality system, understand the regulations NMPA, OECD, FDA, etc., and conduct GAP analysis 6. Maintain QA files and QA file archives 7. WuXi AppTec 2020 Cheque Award Show less
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Education
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上海大学
硕士, 环境工程 -
台州学院
学士, 环境工程