上海相关职位： 行政专员/助理 保健食品申报 备案专员 生产研发 销售工程师 医药辅料技术支持 医药质量审核/药品注册 商务经理—招投标 抗体发现高级研究经理 QC检测员（金山地区） 分析部主管 QA专员/质量管理
周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期： 2017-11-09
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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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