【岗位设立的目的及目标】 负责开展内部的分析性能研究、稳定性研究、分析方法转移和验证等工作，以支持工业产品本土化项目的实施。负责制定方案、撰写报告并执行微生物实验，领导并参与相关活动，包括变更控制及实验室调查等。 【主要职责 】 1. Safety, Health & Environment /安全，健康和环境  确保符合总部EHS方针、本地法规以及ISO14000的需求。 Ensure compliant to global EHS policy, local regulation and ISO 14000 requirements.  学习、掌握并执行国家、政府职能部门、地方的HSE法律法规要求、标准，履行法规要求的HSE责任和义务。 Learn, master and follow HSE laws, regulations, requirements and standards of the country, government functional departments and local governments, and fulfill the HSE responsibilities and obligations required by regulations.  严格遵守公司HSE规章制度，服从公司的HSE管理，并执行本岗位的HSE管理要求，承诺“不伤害自己、不伤害他人、不被他人伤害，保护他人不受伤害“的四不伤害员工职责。 对被赋予的工作活动做好危害辨识、风险评估、应急预案并确保执行安全操作规范。有责任及时汇报HSE隐患及事故。 Strictly comply with HSE rules and regulations, and implement the HSE management requirements of this position. Promise to follow the requirement "do not harm ourselves, do not harm others, do not be harmed by others, and protect others from harm". Carry out hazard identification, risk assessment, and emergency plans for assigned work activities and ensure the implementation of safe operating practices. Responsible for reporting HSE hazards and accidents timely. 2. Quality and Regulation/质量和法规  确保遵守国家药品监督管理局相关法规、ISO 13485 标准以及其他适用行业规范，以支持完成公司目标。 Support the company’s goal of ensuring compliance with NMPA regulations, ISO 13485 standard and other industry codes applicable. 3. Main Accountabilities /日常职责  负责开展内部的分析性能研究、稳定性研究、分析方法转移和验证等工作，以支持工业产品本土化项目的实施。负责制定方案、撰写报告并执行实验，领导并参与相关活动，包括变更控制及实验室调查等。 Responsible for conducting internal analytical performance studies, stability studies, analytical method transfer and validation, and so on to support the implementation of Industry Products Localization Project. Responsible for the protocols, reports and microbial experiments execution, lead and participate in related activities including change control, lab investigations and so on.  支持工业化部门进行产品安全性分析、转移差距分析、风险管路计划、过程风险分析等工作，并提供技术输入以支持临床研究和注册等相关工作。 Support Industrialization to conduct product safety analysis, transfer gap analysis, risk management plan, process risk analysis and so on, provide technical inputs to support clinical studies and registration related and so on.  必要的研究方案/报告的的撰写和执行,对现有产品/工艺问题提供专业的技术指导，以满足产品产能增加或质量提高的需求。 Provide technical study and assessment supporting technical guidance for existed products/processes troubleshooting, protocol/report writing, so to meet production scale-up or quality improvement.  必要时，运用Minitab统计学分析、项目管理、风险分析(如FMEA)、问题解决方法(如精益六西格玛)等技术和方法知识 If necessary, use knowledge of techniques and methods such as Minitab statistical analysis and Project Management, Risk Analysis (e.g. FMEA), Problem Solving Methods (e.g. Lean 6 Sigma)  提供技术评估以支持调查和变更控制管理，并及时执行分配的任务。 Provide technical evaluation to support investigation and change control management, and to perform assigned tasks in time.  支持工厂、集团质量以及监管当局的良好生产规范和ISO 9001/ISO 13485质量体系等审核活动 Supports site, corporate and competent authority quality system audit activities of GMP and ISO 13485 etc.

【知识、语言和经验要求】  本科及以上学历，生物、制药、化学等相关专业，需要有至少5年以上从事微生物研究、分析及项目转移等工作经验。 Bachelor degree or above, major in Biology, Pharmacy, Chemistry etc. and necessary to have at least 5 years of relevant work experience in microbial study, analysis and project transfer.  掌握微生物学知识体系，熟悉微生物培养、接种、分析、鉴定等操作，对微生物特性有较深刻理解者优先。 Rich knowledge of microbiology, familiar with microbial culture, inoculation, analysis, identification and relevant operations, deep understanding of microbial characteristics is preferred.  语言技能：英语和中文听、说、读、写熟练，有欧美外资企业工作经验者优先。熟练操作Word和Excel等办公软件。 Language skills: Proficient in Listening , Speaking, Reading and Writing of both English & Chinese, applicants with working experience in European and American foreign-funded enterprises will be given priority, Proficient in operating office software such as Word and Excel.  熟悉ISO 19001, ISO 13485, ISO 14971, GMP等医疗器械及生物安全等相关的法规规范者优先。 Be familiar with relative medical device regulation and bio-security and other codes, such as ISO 19001, ISO 13485, ISO 14971 and GMP ，will be given priority  有良好的团队合作能力。 Good Interpersonal skill and team player.