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 amplification1、 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 equipment4、 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.