工作内容CONTENT

1. 审核执行前批记录及相关验证文件。Review the template batch record.

2. 起草SOP。Draft SOP.

3. 起草项目及生产相关方案（例如风险评估、事件调查、中间体存放时间等）和报告。Draft the study protocol (e.g. risk assessment, incident investigation, intermediate storage time, etc.) and report for the process of project.

4. 起草生产计划，协调外部门（分析、QA、研发）和部门内部（库房、设备）的工作安排，保证项目顺利进行。Draft the manufacturing schedule. Coordinate the work arrangement of external department (QC, QA, PPD-FD) and internal department (warehouse, equipment) to ensure the smooth progress of the project.

5. 起草客户投诉并制定跟踪后续措施。Draw up customer complaints and follow up measures.

6. 负责生产过程中变更及偏差，并做其对应的评估、调查跟踪及KAPA的实施。Responsible for changes and deviations in the production process, and conduct corresponding assessment, investigation and tracking and KAPA implementation.

7. 负责客户审计及审计回复。Responsible for customer audit and audit response.

8. 解决生产过程突发事件并上报QA。Solve production process emergencies and report to QA.

9. 负责生产车间技术支持。Responsible for technical support of production
workshop.

10. 负责车间生产管理和人员安排。Responsible for workshop production management and personnel arrangement.

11. 负责生产设备报修。Responsible for repair of production equipment.

12. 组织安排操作人员的实操及SOP培训工作。Organize and arrange practical operation and SOP training for operators.

13. 负责新建厂房过程中文件的起草审核。Drafting and reviewing documents in the process of building a new factory.

14. 完成其他相关工作。Execute other related tasks.

教育背景和任职资格EDUCATION BACKGROUND and QUALIFICATION

1. 药物制剂、制药工程或相关专业本科或以上学历。Bachelor’s degree or above in pharmaceutical, electromechanical, mechanical or other related majors.

2. 五年以上生产质量管理或相关工作经验。At least 5 years’ experience in production quality management or related work

3. 了解相关制药法规，如《中华人民共和国药品管理法》和GMP法规。Understand the relevant pharmaceutical laws and regulations, such as “The Drug Administration Law of the PRC” and “Good Manufacturing Practices”

4. 熟悉产品的工艺过程、SOP、质量控制点，掌握关键设备的性能和操作。Familiar with the product process, SOP, quality control point, master the performance and operation of key equipment.

5. 具有工艺问题分析能力、设计方案能力、判断能力、操作能力、与他人沟通能力。Have ability to analyze process problems, design protocols, judge, operate and communicate with others.

6. 具有生产管理的能力。Have the ability to manage the production.

7. 具有独立解决产品工艺问题的能力。Have ability to solve process problems
independently.

8. 熟悉电脑文档操作。Familiar with computer documentation operation.