IT QA- Quality Management System 上海

月薪： 1-3万/月

该公司所有职位
  • 无工作经验
  • 招1人
  • 03-01 发布
  • 五险一金
  • 免费班车
  • 专业培训
  • 年终奖金
  • 定期体检

职位描述

Position Summary: This position is responsible for establishing the IT Quality Management System (QMS) by utilizing the existing Quality procedures and adding industry best practices, maintaining and fine-tuning QMS along the way, ensuring the all computerized systems at WuXi LTD comply with Regulatory requirements (e.g. US FDA 21 CFR Part 11, EU GMP Annex 11, OECD GLP Principle No. 17 and CFDA GMP Appendix I), follow industry best practice (e.g. GMAP 5), and the company’s IT QMS. Essential Job ResponsibilitiesEstablish WuXi LTD IT Quality Management System (QMS) by utilizing the existing Quality procedures and adding industry best practices Ensure the GxP system following the regulation and drive for data integrity resultBuild IT Quality team Ensure all GxP computerized systems (infrastructure, general IT system, and process automation/PA systems) are properly validated prior to go-live Ensure all GxP computerized systems remain in validated status throughout the life cycleChampion the effort of preparations (computerized systems only) for audits from customers and inspections by regulatory bodies example: FDA/CFDA etc.Respond to findings (computerized systems only)from audits and inspections. Working closely with QC, MFG/FFF, ENG, Operation, AIS, QA, and IT to achieve and maintain compliance of computerized systemsLead and act as the key contact person / SME for all issues related to computerized system compliance during routine quality operation, internal/external audits, health authority (HA) inspections and client communication.Lead computerized system validation and quality SME and provide strategic guidance: determine and establish validation requirements for computerized systems based on regulatory, IT QMS, and industry best practices, lead the development of system specific validation plans and strategy using a risk-based approach, etc..Provide CSV and CSQ (computer system quality) training to IT Quality team and across the company key players 人员资质 PERSONNEL QUALIFICATIONCertifications in computer system quality and quality management preferredBachelor or above degree in Computer Sciences, or related field. At least 5+ years of working experiences in the field of computerized system validation and computer system quality in the pharmaceutical industry. Deep knowledge and expertise in related regulatory requirements and industry standards, such as 21 CFR Part 11/210/211, Annex 11 of EU GMP, Appendix I of CFDA GMP, GAMP 5, and ICH Q9/Q10.Proficiency in: SAP, LIMS, MES, DCS, Empower, automation, and other pharmaceutical IT systems; Data Management Systems.Fluent in both English and Chinese in listening, speaking, and writingExcellent training skills in providing both classroom training and on the job trainingLeadership and problem solving cross departments 职能类别： 药品生产/质量管理 质量管理/测试经理(QA/QC经理) 关键字： Quality QMS IT GxP

联系方式

外高桥保税区德林路90号

公司信息

药明康德新药开发有限公司于2000年12月成立，是全球领先的制药、生物技术以及医疗器械研发开放式能力和技术平台公司，在中美两国均有运营实体。作为一家以研究为首任，以客户为中心的公司，药明康德向全球制药公司、生物技术公司以及医疗器械公司提供一系列全方位的实验室研发、研究生产服务，服务范围贯穿从药物发现到推向市场的全过程。药明康德的服务旨在通过高性价比、高效率的研发服务帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。 十多年来，药明康德成功打造了全方位一体化的研发服务技术平台。创建之初，药明康德凭借其在发现化学合成领域的雄厚实力实现了全面发展。近几年来，我们又新增了一系列一体化服务，包括分析服务、生物分析服务、工艺研究、工艺研发服务、API生产服务、药物代谢及其动力学服务、研发生物学、药理学、制剂、毒理学、基因组服务、生物制剂生产服务、抗体及生物诊断试剂的生产和销售服务以及临床研发和产品注册服务等。 从 2000 年 12 月创立至今，药明康德的员工数从4 人增长至 10000 人，实验室由当初仅有的一间增长到近46 万平方米已有及在建研发基地和生产厂房。与此同时，药明康德还在不断增强服务能力，拓宽服务领域，以更好地服务公司持续增长的全球业务需求。作为一家全球领先的医药研发服务公司，药明康德将继续致力于在中美两国为全球客户提供高质量的医药研发服务，帮助研发出更多造福患者的新药及产品。 回望昔年，药明康德已经走过了15年的历程。15年走来，我们见证了新药研发的飞速发展，见证了众多科学家在新药研发中实现梦想，见证了全球2000多家企业攻克越来越多的疾病，见证了越来越多患者脸上渐渐浮现的微笑，同时也见证了药明康德人从无到有将药明康德建成一个无论在亚洲还是在全球医药行业里独一无二的研发生产技术能力平台性公司。 未来我们的发展方向：一是继续将一体化、开放式的研发生产技术能力平台做大做强，继续延揽建立全球最尖端的医药研发技术，包括基因诊断、细胞基因治疗、基因编辑以及一些高端创新药物的研发、生产等。二是更加致力服务中国的大健康产业，通过我们的平台连接“人与健康”，让国际尖端医药技术能为广大国内患者和老百姓所用。 面对2016年，回归成为私营公司的药明康德将更加专注，专注于公司创业之初变革新药研发的梦想。不忘初心，方得始终。药明康德人将继续坚守我们的初心与梦想，在新的征程中，实实在在地推动人类健康。欢迎加入药明康德大家庭，与我们携手一起开启未来，创造未来，享受未来！ 如需了解更多，欢迎访问公司网站 http://www.wuxiapptec.com.cn

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