Test & Metrology Engineer II

Molecular Devices

Molecular Devices

Suzhou, Jiangsu, China
Posted on Thursday, July 11, 2024
  • 负责免疫新产品转移项目的支持工作,完成转移过程中涉及的DHF和DMR文件,并主导参与完成新产品试生产工作。
  • 起草和更新原料标准及原材料检验程序和方法,参与评估供应商的能力。
  • 参与免疫产品新项目过程中生产异常问题的调查,参与根本原因的分析和风险评估、检查和跟踪。
  • 免疫新产品流程的设计,起草和维护产品配料、灌装、包装、检验DMR。
  • 参与包装材料和原材料的供应商认证,并提供(验证)技术支持。
  • 上市后产品各种技术变更实施的跟踪,包含变更后的分析,保证变更的有效性。
  • 了解免疫、生化产品种类、规格、配方、原理、应用要求,熟悉产品的整套文件。
  • 了解免疫临床诊断分析仪器的原理、应用、验证、临床使用和临床结果判别。
  • 完成领导安排的其他工作。

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