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