公司簡介

崗位設(shè)立的目的及目標 / PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB
l 負責蘇州工廠微生物質(zhì)量控制實驗室的日常管理及運營,。
Responsible for the routine management and operation of the microbiological quality control laboratory on Suzhou site.
l 支持工業(yè)化部門的微生物實驗相關(guān)工作,,包括但不限于試劑產(chǎn)品的研究,和儀器產(chǎn)品的驗證。
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 保證法律法規(guī),、標準和梅里??偛课募玫接行ж瀼亍?/p>
Ensure that laws, regulations, standards and BioMérieux global procedures are effectively implemented.
l 把分配到的工作進行組織和協(xié)調(diào),。
Organize and coordinate the assigned work
主要職責 / MAIN ACCOUNTABILITIES
安全,,衛(wèi)生和安全/Safety, Health & Environment
l 在管理職責范圍,貫徹執(zhí)行國家,、政府職能部門,、地方的HSE相關(guān)法律法規(guī)要求,執(zhí)行國家,、地方,、行業(yè)的HSE標準,履行法定的HSE管理義務(wù)并承擔相應(yīng)的職責,,確保所轄部門全員遵守HSE法定義務(wù)和責任.
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 在管理職責范圍,依照公司HSE管理體系要求開展HSE管理活動,,建立并監(jiān)督執(zhí)行年度HSE工作,、活動,在職責范圍內(nèi)對公司的年度HSE指標目標的完成情況負責,。確保所轄部門全員遵守和執(zhí)行公司的HSE管理要求和規(guī)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.
質(zhì)量和法規(guī)符合/ Quality and Compliance
l 和生產(chǎn)、倉庫,、工業(yè)化等部門合作,,確保所有實驗室工作滿足相關(guān)質(zhì)量法規(guī)要求。
Collaborate with Production, Warehouse, Industrialization department and so on to ensure that all lab activities meet relevant quality regulatory requirements.
l 支持體系自查,、內(nèi)部和外部的審計工作,,并在必要時做改正和/或糾正預防措施。
Support self inspection, internal and external audit activities, and take correction and/or CAPA when necessary..
日常實驗室工作/ Routine Lab Work
l 負責日常的微生物實驗室人員管理,、業(yè)務(wù)安排和資質(zhì)培訓
Be responsible for routine QC staff management, business arrangement and training
l 負責微生物實驗所需的標準品,、校準品、質(zhì)控品,、耗材和工具的購買和臺賬維護工作,。
Responsible for the purchase and record maintenance of quality standards, calibrators, controls, consumables and tools required for microbiological experiments.
l 負責維護微生物實驗室管理及檢測等相關(guān)程序文件,滿足質(zhì)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 負責監(jiān)督微生物實驗室的程序文件的執(zhí)行,保證記錄的規(guī)范性,。
Responsible for supervising the implementation of microbiology laboratory procedure documents and ensure the standardization of records.
l 負責檢驗儀器和儀器的日常使用管理,,并保持記錄。
Responsible for the daily use of inspection instruments and equipment management, and keeping records.
l 負責檢驗儀器產(chǎn)品的微生物性能檢測(如需)。
Responsible for performance microbiology testing of instrument products (if necessary).
l 負責實驗室相關(guān)的OOS調(diào)查,,并支持不合格,、偏差及投訴的調(diào)查。
Be responsible for OOS investigation in Lab and support investigation from NC/AR/complaint.
支持工業(yè)化工作/ Support Industrialization Work
l 支持試劑產(chǎn)品的工業(yè)化研究的相關(guān)微生物實驗,,包括但不限于穩(wěn)定性研究等,。
Support related microbiological experiments for industrial research of reagent products, including but not limited to stability studies.
l 支持儀器產(chǎn)品注冊和其相關(guān)微生物實驗,包括但不限于型式檢驗,,產(chǎn)品性能驗證等,。
Support instrument product registration and it’s related microbiological experiments, including but not limited to type testing, product performance verification, etc.
知識、語言和經(jīng)驗要求 / KNOWLEDGE, LANGUAGE AND EXPERIENCE
l 本科及以上學歷,,生物,,藥學,醫(yī)學相關(guān)專業(yè)
Bachelor degree (equivalent) or above educational background, majoring in biology, pharma, medicine or related working experience .
l 至少有5年以上微生物檢驗相關(guān)工作經(jīng)驗,,并有3年以上的實驗室管理經(jīng)驗,,熟悉實驗室
At least 5 years of relevant working experience in microbiological experiments, and 3 year experience as lab supervise, be familiar with lab management.
l 語言技能:英語和中文聽、說,、讀,、寫熟練。
Language skills: Proficient in Listening , Speaking, Reading and Writing of both English & Chinese.
l 熟練的Word Excel等辦公軟件的操作,。
Skilled with Microsoft Word and Excel.
l 有良好的團隊合作能力,。
Good Interpersonal skill and team player .
l 熟悉ISO 19001, ISO 13485 和醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范等相關(guān)的法規(guī)規(guī)范
Be familiar with relative medical device regulations, such as ISO 19001, ISO 13485 and GMP.