Equipment Qualification/ Maintenance Scientist 上海

月薪： 6-8千/月

该公司所有职位
  • 无工作经验
  • 招1人
  • 11-09 发布

职位描述

职位描述： KEY ACCOUNTIBILITIES:?Qualification, calibration and maintenance managementDraft and review the procedure and report of equipment instrument qualificationCalibrate and qualify the equipment instrument according to the documents or SOP(s)Follow up the maintenance plan and preventive maintenance documents. Ensure the SOPs and procedures are followed during all stages of calibration/ qualificationPrepare monthly summary report for instrument validation related activitiesCalibrate the pipettes according to the SOPAssume responsibility for assigned refrigerators, maintaining them in proper calibration and working order according to the appropriate SOP if neededBe responsible for temperature alarm system logbook and print reports of network monitor system?Change Control managementMonthly monitoring of the progress of raised changes and follow up with action plansAble to write change controls, deviations and CAPAs in a logical and clear manner, and review these documentsYearly trend analysis of environmental monitoring results for the purified water system, nitrogen system, HVAC, compressed air system and production equipmentReview of current equipment validation practices and propose changes to improve these practicesFulfill a consultant role in the field of equipment validation for QA and the production departmentREQUIREMENTS:?Knowledge of cGMP requirements?A minimum of two years of GMP experience in a biotech or sterile pharmaceutical manufacturing environment, or the equivalent, is desired.?Prior work in maintaining GMP biotechnology and/or sterile process equipment is required is desired?Proficient in computer skills and MS Office applications?Knowledge of validation test instruments such as Kaye Validator is desired?Excellent written and verbal communication skills.?Excellent written and spoken English communication skills 职能类别： 生物工程/生物制药

联系方式

上海市外高桥保税区富特中路288号

公司信息

药明生物（WuXi Biologics）是香港上市公司（代码：2269），我们是全球领先的开放式、一体化生物制药能力和技术平台，旗下包括无锡药明康德生物技术股份有限公司、上海药明生物技术有限公司、苏州药明康德检测检验有限责任公司，并在美国和英国设有子公司。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务，帮助任何人、任何公司发现、开发及生产生物药，实现从概念到商业化生产的全过程，加速全球生物药研发进程，降低研发成本，造福病患。目前，公司规模达到2300多人，有200多位拥有海外高等学位和工作经验的海归科学家，拥有丰富的欧美市场抗体开发、生产、质量控制、临床前研究和注册的经验，打造了世界一流的生物药研究、开发及生产团队。 更多信息，请登录公司官网：http://www.wuxibiologics.com.cn/

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企业入驻日期： 2017-11-09

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