About this role
Job Description:
- 根据生产任务和定期监测计划,实施环境监测工作,包括尘埃粒子、浮游菌、(人员)表面菌及沉降菌监测;
Perform environmental monitoring in accordance with the production schedule and routine monitoring plan, including the monitoring of non-viable airborne particle, viable airborne particle, (personnel) surface microbe and settling microbe.
- 按计划对纯化水、注射用水、纯蒸汽及工艺气体进行监测,负责相关取样及微生物相关的检验工作。
Monitor purified water, water for injection, pure steam, and process gases according to the approved schedule, and be responsible for relevant sampling and microbiological testing.
- 负责原辅料及包装材料的取样工作;
Be responsible for sampling raw materials, excipients, and packaging materials.
- 执行微生物限度检查、细菌内毒素检查及无菌检查;
Perform microbial limit tests, bacterial endotoxin tests, and sterility tests.
- 开展微生物鉴定及微生物相关方法学验证工作;
Conduct microbial identification and microbiology-related method validation activities.
- 负责培养基配制及培养基性能测试;
Be responsible for culture medium preparation and performance testing.
- 执行包装材料的物理 / 微生物检验。
Perform physical and microbiological testing of packaging materials.
- 完成上级安排的其他任务。
Fulfil other routine work assigned by the superior.
## Location:
Ferring China Production