Job Responsibilities/工作职责
1. Participate in the material release activity.
物料放行工作。
2. Participate in the compliance review of Material Management related GMP documents and records.
参与物料管理相关GMP文件和记录的合规性审核。
3. Participate in the handling of Material Management related quality events, including deviation, change control, CAPA, etc.
参与物料管理相关质量事件的处理，包括偏差、变更、纠正与预防措施等。
4. Oversee GMP compliance of the operation and site management of Material Management.
监督物料管理的操作和现场管理的GMP合规性。
5. Review relevant qualification/validation protocol and report.
审核相关确认/验证方案和报告。
6. Participate in the internal audit (self-inspection), external audit and supplier audit.
参与内审（自检）、外审和供应商审计。
7. Complete the other QA tasks as assigned.
完成分配的其他QA工作。
Job Requirements/岗位要求
1. College degree or equivalent and above, major in Biology or Pharmacy is preferred.
专科及以上或同等学历，生物或制药相关专业优先。
2. Experience in a quality regulated industry, pharmaceutical or medical device is preferred. Experience in the biologic quality environment is a plus.
有质量监管行业、制药或医疗器械经验者优先。有生物质量环境经验者优先。
3. Proficiency in the use of common Microsoft Office Applications.
熟练使用常用Microsoft Office应用程序。
4. Have knowledge of GMPs and related guidelines and regulatory requirements.
了解GMP及相关指南和法规要求。
5. Good written and oral English skills is preferred.
书面和口语英语优秀者优先。