岗位职责: 61 负责与销售、技术同事沟通,准备相容性等项目方案及报告,跟进项目进展,沟通解决出现的技术问题。 Be responsible for communicating with sales and technical staff; prepare E&L and other project protocol & report; follow up the schedule and settle the technical issue during process. 61 掌握2种及以上大型分析仪器的原理与应用,如GC-MS, LC-RID/CAD, LC-MS, LC-MS/MS, ICP-OES, ICP-MS等; Master the principle and application of two or more instruments, such as GC-MS, LC-RID/CAD, LC-MS, LC-MS/MS, ICP-OES, ICP-MS etc. 61 具备丰富的色谱、质谱等分析知识,可独立解决工作中遇到的各类问题; Process a good knowledge of spectroscopy, chromatography. Resolve technical issue and perform trouble shooting on daily operation independently; 61 支持QA追踪处理客户投诉、CAPA以及进行OOS, deviation调查 Support QA on complain, CAPA follow up and OOS, deviation investigation. 61 支持来自官方和客户的审核; Support regulatory authorities and client inspection if necessary;
任职条件:
61 主修:化学、药学、分析等相关专业;硕士或本科学历; Major: Chemistry, Pharmaceutical, Analysis; Master or Bachelor degree; 61 具有2-3年工作经验,有第三方检测公司工作经验者优先; Have 2-3years working experience, especially in a third-party testing company; 61 熟练操作办公室软件; Familiar with Office software, such as Word, Excel, outlook and PowerPoint; 61 工作认真、仔细、踏实,可以在压力下积极工作; Working carefuly and reliably, positively under pressure; 61 良好的沟通技能和团队合作意识。 Better communication skills and better sense of teamwork.
关键胜任力: 61 熟悉药包材、医疗器械、一次性生产系统和组件等相容性研究的法规、指南及行业标准。 Familiar with regulations, guidelines and industry standards for E&L of drug packaging systems, medical devices, plastic components and systems used to manufacture, etc 61 有很强的快速学习能力,可独立查阅英文资料,阅读英文文献。 Have strong quick learning capability, can independently track English literature and read English literature.