锦鲤求职岗位描述
掌握制剂生产流程及岗位生产操作步骤；掌握一类及以上设备或GMP生产流程；了解技术转移放大风险点及流程
Master the manufacturing process of preparations and manufacturing operation steps of posts；Master one or more types of equipment or GMP manufacturing process；Understand the risk points and process of Tech Transfer amplification
1、 参与车间的生产活动 。
Participate in the manufacture activities.
2、 熟悉预充式注射器半自动灯检机及全自动灯检机等制剂生产设备的工作原理
Familiar with the working principle of manufacturing equipment such as semi-automatic visual inspection machine and automatic visual inspection machine for pre-filled syringe.
3、 熟悉人工目检、半自动目检以及全自动灯检的相关标准操作规程
Familiar with the standard operating procedure of MVI, SAVI and AVI.
4、 参与车间设备清洁。
Participate in equipment cleaning in workshop.
5、 参与工序文件升版。
Revision of documents involved in process.
6、 参与车 间的验证活动 。
Participate in the validation activities.
7、 了解制剂验证的基本概念，法规指南要求 。
Understand the basic validation concept and the requirements of regulation and guidance.
8、 了解 cGMP法规要求 。
Understand the requirements of cGMP regulation.
专科及以上，生物，化学工程，食品，制药，机械工程/自动化相关专业
Specialty or above, biology, chemical engineering, food, pharmaceutical, mechanical engineering/automation related specialty
专科：2年以上专业领域经验
Specialty: Over 2 years of experience in a specialty area
本科：经验无要求
Undergraduate: Experience not required
具有GMP知识和相关工作经验者优先。 Persons with knowledge and working experience in GMP are preferred.
远距离和近距离测试，裸眼视力均应为4.9或以上（矫正视力应为5.0或以上），无色弱、色盲。 Distance and near testing, uncorrected visual acuity should be 4.9 or above (corrected visual acuity should be 5.0 or above), no color weakness, color
blindness.