锦鲤求职岗位描述
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：8年以上专业领域经验
Specialty: Over 8 years of experience in a specialty area
本科：5年以上专业领域经验
Undergraduate: Over 5 years of experience in a specialty area
硕士：3年以上专业领域经验
Master: Over 3 years of experience in a specialty area
精通制剂生产流程及岗位生产操作步骤；精通一类及以上设备或GMP生产流程；认证为SME（Layer 1）
独立完成SOP/MBR的撰写; 掌握技术转移放大风险点及流程
Proficient the manufacturing process of preparations and manufacturing operation steps of posts；Proficient one or more types of equipment or GMP manufacturing process；Qualified as SME (Layer1); Completed SOP/MBR independently; Master 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、 熟悉灭菌柜 /清洗机等制剂生产设备的操作及工作原理
Familiar with the operation and working principle of manufacturing equipment, autoclave/washer etc.
3、 熟悉衡器、一次性混匀系统、蠕动泵、完整性测试仪等配液相关生产设备的操作和工作原理
Familiar with the operation and working principle of balance, single-use mixing system, peristaltic pump, integrity tester and other related equipment
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.
9、 了解 cGMP法规要求 。
Understand the requirements of cGMP regulation.
10、 根据需要领导团队安全审计和巡检，并与所有员工一起倡导强烈的安全精神
Leads team safety audits and walk downs as required and advocates a strong safety ethos with all employees.
11、 根据需要积极参与风险评估
Actively participates in risk assessments as required.