1.负责对GMP产品生产和包装进行监控
Responsible for manufacturing and packaging monitoring of GMP product
2.负责制剂车间房间清场放行及生产车间现场常规监控
Responsible for releasing room of line clearance and routine monitoring of production area
3.负责执行产品AQL
Responsible for performing AQL sampling
4.负责审核主生产记录和批生产记录
Responsible for reviewing the Master Batch Record (MBR) and Batch Production Record (BPR)
5.负责审核制剂车间计算机化系统电子数据
Responsible for reviewing electronic data generated by computerized system
6.负责审核制剂车间日常运行相关的SOPs，方案，报告等。
Responsible for reviewing SOPs, protocol and report etc. of the drug product workshop
7.负责审核制剂车间相关偏差，变更，CAPA
Responsible for Reviewing DP related deviation, change control and CAPA.
8.负责支持DP相关审计工作
Responsible for supporting DP related audits
岗位要求：
1、药学、生物工程或相关专业，本科及以上学历
Education: Pharmacy, bioengineering or related specialty
2.具备较强的 GMP意识、了解无菌工艺方面的法律法规
Strong GMP awareness, understanding of aseptic process laws and regulations