工作内容CONTENT

1. 按照已批准的生产规程/批记录进行制剂的生产。
Produce drug product according to approved production procedure/ batch record.
2. 按照项目计划安排小组人员班次生产。
Arrange the production personnel according to project plan.
3. 审核所有的现场记录，确保记录完整并已签名。
Review all site records and ensure that these are completed and signed.
4. 确保生产设施是清洁的，在必要时消毒，对已清洁的设备进行目视检查及签发清场“清场合格证”正副本。
Make sure that production facilities are cleaned and disinfected when necessary, and perform visual check for cleaned equipment and issue “Clearance Certificate”(Original and Copy) for clearance.
5. 确保生产设备被校验并有效。
Make sure that the equipment calibrations are performed and valid.
6. 确保验证方案和报告的审核与执行。
Make sure that validation protocols and reports are reviewed and executed.
7. 确保新的或经过改造的（必要时）生产设施和设备通过确认。
Make sure that new or modified (when necessary) facilities and equipment are qualified.
8. 确保生产现场整洁，对设备设施实行定置定位管理。
Make sure that the production site is tidiness, and conduct positioning management for facilities and equipment.
9. 确保操作人员在GMP 制剂实验室操作、行为符合SOP规定。
Make sure that the operation and action of operator in PPD_GMP-Lab are following SOP.
10. 确保GMP制剂实验室文件记录完整，及时。
Make sure that all records of PPD_GMP-Lab are completed in time.
11. 调查和评估生产偏差，并上报QA。
Investigate and evaluate the production deviations, and report to QA.
12. 起草SOP、验证文件。
Draft SOPs and validation documents.
13. 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专科或以上学历。
College degree or above in pharmaceutical preparation, pharmaceutical engineering or related majors
2. 两年以上生产管理或相关工作经验。
At least 2 years’ experience in production 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. 熟悉电脑文档操作。
Familiar with computer documentation operation