Assistant Engineer,QA
质量体系管理
Quality systems managementResponsibilities:
- 为泰州生产基地创建和维护质量管理体系文件
- Creating and maintenance quality management system
- procedure for BM manufacturing procedure
- 质量事件的调查
- Investigation of quality issues
- 偏差和CAPA 的管理
- Deviation and CAPA management
- 变更管理
- Change control management
- 参与自检
- To be involved in the self-inspection
文件审核
Document review
- 审核验证/确认文件
- Review qualification and validation documents.
- 审核标准操作规程
- Review standard operating procedure
- 审核质量系统管理文件
- Review quality management system documents
不合格品及退货处理
To handle rejected and returned product
- 审核批生产记录
- Review production sheet
- 负责和生产部门一起解决生产过程中的质量问题
- Responsible for solving the quality issues with operation team
客户投诉
Customer complaint
- 协调处理客户投诉并在投诉管理系统中记录
- Coordinate with related functions to deal with customer complaint and documentation in complaint system
- 定期对客户投诉情况进行分析
- Trending analysis on customer complaints
- 投诉事件的调查
- Investigation of customer complaints
物料和产品放行
Raw material and product release
- 如经授权，负责中间产品、原辅料、包装材料和成品的放行
- If authorized, take responsibility for bulk product, API, excipients and packing materials release
处理QA 有关的日常事务
Management of QA affairs
- 确保完成QA 的部门目标
- Ensure to fulfill the KPIs of QA
- 质量的持续改进
- Quality continuous improvement
- 年度产品审核
- Annual product review
- 生产现场走动管理
- QA Genba Walk
- 负责KPI 的监控
- Responsible for quality KPI measurement
- 负责IPC 的管理
- Responsible for the IPC management
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
