岗位：全职
年龄：不限
工作内容CONTENT
1. 协助经理审核制剂主批记录。
Assist manger in reviewing the masterbatch record of drug product.
2. 审核执行后的制剂批记录。
Review the batch record after the execution of drug product.
3. 起草或审核生产相关SOP。
Draft andreview the related SOP of the manufacturing.
4. 起草项目及生产相关方案和报告，如工艺试制方案和报告。
Draft protocol andreport related to project andproduction, such as protocol andreport of process trial.
5. 起草生产计划。
Draft the manufacturing schedule.
6. 起草制剂生产工艺规程。
Draft the process procedure forthe production of drug product.
7. 起草清洁确认或验证方案和报告。
Draft the protocol andreport forcleaning verification orvalidation.
8. 对工艺的变更做出评估。
Evaluate the changes of process.
9. 负责生产过程中工艺执行情况的检查。
Responsible forinspecting the implementation of process during production.
10. 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.
11. 按照项目计划安排小组人员班次生产。
Arrange the production personnel according to project plan.
12. 审核所有的现场记录，确保记录完整并已签名。
Review all site records andensure that these are completed andsigned.
13. 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。
Make sure that production facilities are cleaned anddisinfected when necessary, andperform visual check forcleaned equipment.
14. 确保生产设备被校验并有效。
Make sure that the equipment calibrations are performed andvalid.
15. 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 ormodified （when necessary） facilities andequipment are qualified.
16. 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, andconduct positioning management forfacilities andequipment.
17. 确保操作人员在制剂生产车间操作、行为符合SOP规定。
Make sure that the operation andaction of operatorin DP Plant are following SOP.
18. 确保制剂生产车间文件记录完整，及时。
Make sure that all records of DP Plant are completed in time.
19. 调查和评估生产偏差，并上报QA。
Investigate andevaluate the production deviations, andreport to QA.
20. 完成其他相关工作。
executeother related tasks.
教育背景和任职资格EDUCATION BACKGROUND andQUALIFICATION
1. 药物制剂、制药工程或相关专业专科或以上学历。
College degree orabove in pharmaceutical preparation, pharmaceutical engineering orrelated majors.
2. 三年以上在GMP条件下的口服固体制剂生产管理或质量管理或相关工作经验。
At least 3 years’ experience of OSD production management orquality management orrelated work in GMP environment.
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。
Understandthe relevant pharmaceutical laws andregulations, 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, masterthe performance andoperation 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 andcommunicate with others.
6. 具有生产协调管理的能力。
Have the ability to manage andcoordinate 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.
