药明生物
DP14-PFS 目检工程师
岗位职责
JOB RESPONSIBILITY
参与车间的生产活动。 Participate in the manufacture activities.
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.
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.
参与车间设备清洁。 Participate in equipment cleaning in workshop.
参与工序文件升版。 Revision of documents involved in process.
参与车间的验证活动。 Participate in the validation activities.
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.
了解cGMP法规要求。 Understand the requirements of cGMP regulation.
任职要求
Job Requirements： 专科及以上学历，生物、化学、医药工程等相关专业，或具有同等工作经验的人员。 Junior college degree (or above) with major in Biology, Chemistry or Pharmaceutical Engineering or related Science major or person with equivalent experiences. 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.
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