Aseptic Manufacturing Technician

Basic qualifications:

掌握无菌制剂生产工艺及生产线设备,具备良好的无菌操作及设备操作技能,按计划完成配制、分装/冻干、轧盖工序的生产活动,确保天元工厂保质、保量并及时地完成制剂生产及供应目标。

Preferred qualifications:

在其他大型生物制药企业从事生产车间操作(特别是无菌制剂)优先

Details:

具备无菌操作知识,掌握无菌制剂生产工艺及生产线设备,具备良好无菌操作及设备操作技能,负责本岗位相关SOP的制修订。

  1. 按计划完成配制、分装/冻干、轧盖工序的相应无菌生产活动,主动识别岗位安全及产品质量风险并及时按程序上报,确保无菌生产区域内所有活动严格按照已批准的SOP执行并符合EHS及质量要求。

  2. 负责配制、分装/冻干、轧盖工序的一般级别偏差调查、变更申请以及CAPA行动。

  3. 按计划执行相关的设施设备调试、确认、维保、退役等活动,确保相关设施设备符合生产及质量活动需要。

  4. 按计划执行培养基模拟验证方案。

  5. 利用各平台,如Workday/Mylearning/PDP等关注自身绩效及个人发展,完成既定的个人培训计划。

  6. 完成上级领导交办的其他工作任务。

Contact information:

You may apply for this position online by selecting the Apply now button.

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