设施和设备验证专员 上海

月薪： 8-12万/年

该公司所有职位
  • 2年经验
  • 本科
  • 招若干人
  • 12-12 发布

职位描述

职位描述： Responsibilities:1.Draft procedure and report of equipment/instrument qualification.2.Perform the execution of equipment/instrument qualification.3.Coordinate with ENG department in terms of validation instrument calibration.4.Responsible for validation/qualification annual review, requalification, deviation, change control, investigation, CAPA, and/or the other GMP activities related to facility, equipment and cleaning. Able to write change controls, deviations and CAPAs in a logical and clear manner and follow up progress.5.Support in process/analytical method/cleaning validation coordinating with other related department/team.6.Prepare monthly/weekly summary report for equipment/instrument qualification related activities.7.To communicate with and assist different group or department in a timely manner to fulfill the work assignment with efficiency.8.Conduct the work assignments in compliance with cGMP regulations whenever applicable.Qualification:1.BS degree in chemical, mechanical, electrical engineering or equivalent practical working experience.2.A minimum of two years GMP experience in a biotech or sterile pharmaceutical manufacturing environment.3.Knowledge of cGMP requirements.4.Knowledge of validation test instruments such as Kaye, Fluke, TESTO, and air sampler.5.Knowledge of facility engineering/design such as HVAC system, clean facility is a plus.6.Solid experience in process/analytical method/cleaning validation is highly preferred.7.Proficient in computer skills and MS Office applications.8.Excellent written and verbal communication skills.9.Excellent written and spoken English communication skills is preferred. 职能类别： 生物工程/生物制药 药品生产/质量管理

联系方式

上海市外高桥德林路90号

公司信息

全球肿瘤细胞免疫疗法的领军企业Juno Therapeutics(NASDAQ：JUNO)与药明康德宣布在中国建立上海药明巨诺生物科技有限公司(JW Biotechnology Co. Ltd），双方将结合Juno世界领先的嵌合抗原受体技术(CAR-T)和T细胞受体(TCR)技术，以及药明康德的研发生产平台及公司丰富的中国本地市场经验，联合打造中国领先的细胞疗法公司，为血液肿瘤和实体肿瘤病人开发创新的细胞免疫疗法。

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