岗位设立的目的及目标 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB

l 负责苏州工厂微生物质量控制实验室的日常管理及运营。

Responsible for the routine management and operation of the microbiological quality control laboratory on Suzhou site.

l 支持工业化部门的微生物实验相关工作，包括但不限于试剂产品的研究，和仪器产品的验证。

Support work related to microbiological experiments for Industrialization department, including but not limited to study on reagent products and the verification for instrument products.

l 保证法律法规、标准和梅里埃总部文件得到有效贯彻。

Ensure that laws, regulations, standards and BioMérieux global procedures are effectively implemented.

l 把分配到的工作进行组织和协调。

Organize and coordinate the assigned work

主要职责 / MAIN ACCOUNTABILITIES

安全，卫生和安全/Safety, Health & Environment

l 在管理职责范围，贯彻执行国家、政府职能部门、地方的HSE相关法律法规要求，执行国家、地方、行业的HSE标准，履行法定的HSE管理义务并承担相应的职责，确保所辖部门全员遵守HSE法定义务和责任.

Within the scope of management responsibilities, follow the HSE-related laws and regulations of the country，government functional departments as well as local governments; Implement national, local, and industrial HSE standards; Perform statutory HSE management obligations and take corresponding responsibilities to ensure that all employees follow HSE legal obligations and responsibilities;

l   在管理职责范围，依照公司HSE管理体系要求开展HSE管理活动，建立并监督执行年度HSE工作、活动，在职责范围内对公司的年度HSE指标目标的完成情况负责。确保所辖部门全员遵守和执行公司的HSE管理要求和规定。

Within the scope of management responsibilities, carry out HSE management activities in accordance with the HSE management system requirements, establish and supervise the implementation of annual HSE work and activities, and be responsible for the completion of annual HSE goals. Ensure that all employees in the departments follow HSE management requirements and regulations.

质量和法规符合/ Quality and Compliance 

l 和生产、仓库、工业化等部门合作，确保所有实验室工作满足相关质量法规要求。

Collaborate with Production, Warehouse, Industrialization department and so on to ensure that all lab activities meet relevant quality regulatory requirements.

l 支持体系自查、内部和外部的审计工作，并在必要时做改正和/或纠正预防措施。

Support self inspection, internal and external audit activities, and take correction and/or CAPA when necessary..

日常实验室工作/ Routine Lab Work

l 负责日常的微生物实验室人员管理、业务安排和资质培训

Be responsible for routine QC staff management, business arrangement and training

l 负责微生物实验所需的标准品、校准品、质控品、耗材和工具的购买和台账维护工作。

Responsible for the purchase and record maintenance of quality standards, calibrators, controls, consumables and tools required for microbiological experiments.

l 负责维护微生物实验室管理及检测等相关程序文件，满足质量和生物安全要求。

Responsible for maintaining relevant procedural documents such as microbiology laboratory management and testing, meet quality and biosafety requirements..

l 负责监督微生物实验室的程序文件的执行，保证记录的规范性。

Responsible for supervising the implementation of microbiology laboratory procedure documents and ensure the standardization of records.

l 负责检验仪器和仪器的日常使用管理，并保持记录。

Responsible for the daily use of inspection instruments and equipment management, and keeping records.

l 负责检验仪器产品的微生物性能检测（如需）。

Responsible for performance microbiology testing of instrument products (if necessary).

l 负责实验室相关的OOS调查，并支持不合格、偏差及投诉的调查。

Be responsible for OOS investigation in Lab and support investigation from NC/AR/complaint.

支持工业化工作/ Support Industrialization Work

l 支持试剂产品的工业化研究的相关微生物实验，包括但不限于稳定性研究等。

Support related microbiological experiments for industrial research of reagent products, including but not limited to stability studies.

l 支持仪器产品注册和其相关微生物实验，包括但不限于型式检验，产品性能验证等。

Support instrument product registration and it’s related microbiological experiments, including but not limited to type testing, product performance verification, etc.

知识、语言和经验要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE

l 本科及以上学历，生物，药学，医学相关专业

Bachelor degree (equivalent) or above educational background, majoring in biology, pharma, medicine or related working experience .

l 至少有5年以上微生物检验相关工作经验，并有3年以上的实验室管理经验，熟悉实验室

At least 5 years of relevant working experience in microbiological experiments, and 3 year experience as lab supervise, be familiar with lab management.

l 语言技能：英语和中文听、说、读、写熟练。

Language skills: Proficient in Listening , Speaking, Reading and Writing of both English & Chinese.

l 熟练的Word Excel等办公软件的操作。

Skilled with Microsoft Word and Excel.

l 有良好的团队合作能力。

Good Interpersonal skill and team player .

l 熟悉ISO 19001, ISO 13485 和医疗器械生产质量管理规范等相关的法规规范

Be familiar with relative medical device regulations, such as ISO 19001, ISO 13485 and GMP.