Job Description

Roles/Responsibilities

职责

• Monitor the process critical control point based on risk assessment outputs.

基于风险评估输出监控工艺过程关键控制点。

• On-site quality management of Drug Product/ADC, to ensure that the production activities and on-site management could meet regulations and BeiGene’s requirements.

负责制剂生产工序/ADC生产的现场质量管理，确保生产活动及现场管理符合GMP和法规要求。

• Ensure timely reporting of quality event, support the investigations and risk assessment.

确保及时向上汇报质量事件，协助质量事件的调查及风险评估。

• Supervise the implementation of Data Integrity policy and provide related knowledge to Production.

监督数据可靠性政策的执行，向生产部门提供相关的知识。

• Responsible for production batch record review.

负责批生产记录关键质量控制点的审核。

• Responsible for audit trail review.

负责审计追踪审核。

Responsible for validation protocol and report review, validation deviation report review.

负责验证方案及报告的审批，负责验证偏差报告的审批。

• Supervise the implementation of rejected products disposal.