IT QA 工程师 IT QA Engineer
广州燃石医学检验所有限公司
- 公司规模:1000-5000人
- 公司性质:民营公司
- 公司行业:制药/生物工程
职位信息
- 发布日期:2019-10-23
- 工作地点:上海-闵行区
- 招聘人数:1人
- 工作经验:2年经验
- 学历要求:本科
- 职位月薪:1-1.5万/月
- 职位类别:技术支持/维护工程师
职位描述
主要职责:
? 根据国内外GxP相关法规要求,撰写公司GxP计算机化系统,如LIMS系统的体系文件、SOP等,保证系统的合规及有效运行。
? 协助IT质量管理经理对公司GxP相关计算机化系统生命周期所涉及的各种活动,包括外部药厂审计、验证、使用、维护、退役等的管理工作。
? 协助IT质量管理经理建立有效的计算机化系统数据管理流程,保证GxP相关数据的可靠性,及数据安全。
? 参与GxP相关计算机化系统的测试或复核工作。
资历要求:
? 从事过生物医药行业相关计算机化系统体系建立及维护
? 了解CFR part 11,GAMP5数据完整性等GxP相关的法规、指南
? 工作认真,踏实勤奋,人品端正,有一定的抗压能力
? 良好的人际交往能力,较强的协调能力,优秀的文档撰写能力
教育背景要求:
? 本科及以上学历;
? IT或质量管理类相关专业。
职业经验:
? 有GxP(GCP) 行业质量管理类工作经验者优先;
职能类别:技术支持/维护工程师
公司介绍
关于燃石医学
燃石医学(纳斯达克代码:BNR)成立于2014年,公司使命为“用科学守护生命之光”,专注于为肿瘤精准医疗提供具有临床价值的二代基因测序(NGS)。公司业务及研发方向主要覆盖:1)基于NGS的肿瘤患病人群检测,6年间,燃石累计检测样本超过18.5万例,在中国市场份额领跑行业;2)基于NGS的癌症早检,目前已经进入临床验证阶段。
燃石医学于2018年7月率先获国家药品监督管理局(NMPA)颁发的中国肿瘤NGS检测试剂盒,在体外诊断领域具有里程碑式意义。实验室获得广东省临检中心颁发的 “高通量测序实验室”技术审核,以及得美国CLIA和CAP实验室质量体系资质认证。公司将继续致力于开发创新可靠的NGS检测产品,推动肿瘤精准医疗领域的发展。
About Burning Rock
Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to Guard Life via Science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, with the leading market share in China and over 185,000 tissue and liquid-based tests completed cumulatively, and ii) NGS-based cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.
In July 2018, Burning Rock received the first approval for a tumor NGS kit by the National Medical Products Administration (NMPA), which is a significant milestone in the field of in vitro diagnosis in China. Burning Rock’s laboratory has obtained the technical certification of “High-throughput sequencing laboratory” issued by Guangdong Center for Clinical Laboratory, and the CLIA and CAP laboratory quality system certification. The company continues to be committed to the development of innovative and reliable NGS testing products and promoting the development of precision medicine in oncology.
燃石医学(纳斯达克代码:BNR)成立于2014年,公司使命为“用科学守护生命之光”,专注于为肿瘤精准医疗提供具有临床价值的二代基因测序(NGS)。公司业务及研发方向主要覆盖:1)基于NGS的肿瘤患病人群检测,6年间,燃石累计检测样本超过18.5万例,在中国市场份额领跑行业;2)基于NGS的癌症早检,目前已经进入临床验证阶段。
燃石医学于2018年7月率先获国家药品监督管理局(NMPA)颁发的中国肿瘤NGS检测试剂盒,在体外诊断领域具有里程碑式意义。实验室获得广东省临检中心颁发的 “高通量测序实验室”技术审核,以及得美国CLIA和CAP实验室质量体系资质认证。公司将继续致力于开发创新可靠的NGS检测产品,推动肿瘤精准医疗领域的发展。
About Burning Rock
Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to Guard Life via Science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, with the leading market share in China and over 185,000 tissue and liquid-based tests completed cumulatively, and ii) NGS-based cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.
In July 2018, Burning Rock received the first approval for a tumor NGS kit by the National Medical Products Administration (NMPA), which is a significant milestone in the field of in vitro diagnosis in China. Burning Rock’s laboratory has obtained the technical certification of “High-throughput sequencing laboratory” issued by Guangdong Center for Clinical Laboratory, and the CLIA and CAP laboratory quality system certification. The company continues to be committed to the development of innovative and reliable NGS testing products and promoting the development of precision medicine in oncology.
联系方式
- Email:simin.huang@brbiotech.com
- 公司地址:广州国际生物岛星岛环北路5号(燃石医学)
- 电话:17710099363