微生物技術(shù)員崗位的主要職責(zé)英文

　　微生物技術(shù)員負(fù)責(zé)執(zhí)行原輔料、包裝材料、中間產(chǎn)品的取樣。下面是第一范文網(wǎng)小編整理的微生物技術(shù)員崗位的主要職責(zé)英文。

　　篇一

　　執(zhí)行原輔料、包裝材料、中間產(chǎn)品的取樣

　　Raw materials, excipients and intermediate sampling

　　執(zhí)行日常微生物相關(guān)的檢驗(yàn)，包括微生物限度檢查、細(xì)菌內(nèi)毒素檢查及無菌檢查等

　　Perform routine microbial related analysis, including microbial limit test, endotoxin test and sterility test

　　水系統(tǒng)及潔凈環(huán)境的日常監(jiān)控

　　Water system and clean environment monitoring

　　培養(yǎng)基、菌懸液及其他實(shí)驗(yàn)相關(guān)試劑的制備

　　Preparation of culture media, buffer solution and microbial strain for testing

　　協(xié)助OOS/OOT/偏差的調(diào)查

　　Asist OOS/OOT/Non-compliance investigation

　　職位要求：

　　了解中國藥典、美國藥典、歐洲藥典及GMP/cGMP/歐盟GMP的相關(guān)要求

　　Understand the ChP/USP/EP and the GMP/cGMP/EU GMP

　　熟悉無菌檢查、微生物限度檢查、細(xì)菌內(nèi)毒素檢查等藥品微生物的檢測及方法驗(yàn)證

　　Familiar with the sterility test/microbiology limit test/endotoxin test and also the TMV

　　熟練掌握細(xì)菌內(nèi)毒素檢測儀器、無菌檢查隔離器、脈動(dòng)真空滅菌柜、微生物鑒定儀等常用設(shè)備的使用

　　Familiar with the usage of common equipment such as endotoxin testing equipment, isolator, autoclave, ID detector, etc

　　篇二

　　Principle Job Accountabilities 工作職責(zé)描述

　　Timely performs microbiological testing according to work instructions on water, product, and the factory environment to ensure compliance to regulatory and company standards.

　　Has the authority and responsibility to timely quarantine and label material or product that fails microbiological specifications in order to ensure that non-conforming material or product is not used or released.

　　Using calibrated equipment timely performs routine testing of in-coming raw materials and packing materials, in-process materials, QA final releasing test and other special test to ensure compliance to company standards.

　　Calibrate equipment as required to ensure compliance to company work instructions.

　　Release or block the batch in SAP based on the testing results & final decision timely.

　　Preparation of batch COC & COA for releasing timely.

　　Issue deviation in TW system for lab OOS as required and investigate lab OOS in terms of sample, equipment, personnel, method etc., Take quick actions for the lab related findings.

　　Ensure that all documentation is fully completed – maintains laboratory logs and records to ensure traceability.

　　Develop new test methods as required and ensure the timely updating of Quality System documentation

　　Timely reports to QA lab supervisor any abnormal issues to ensure timely resolutions

　　Communicate with related department for shift issue (equipment, environment, sample etc.,) that has impact to testing timely.

　　Responsible for performing internal audits especially in regard to areas that are microbiological sensitive

　　Responsible for training staff in regard to microbial issues and GMP, 5S, SOPs, etc.

　　Manage all resources associated with the completion of microbiological activities to agreed schedules and highlight and make proposals to management where resources do not match requirements.

　　Ensure continued professional development to maintain current knowledge on microbiological requirements for medical devices and aqueous products

　　Input into RB best practice forums regarding microbiological activities and implement best practice from other RB sites.

　　Must perform environmental duties such as segregation of waste and following GMPs (Good Manufacturing Practices) in order to comply with ISO 14001.

　　Must comply with company health and safety procedures and policies and must immediately report any unsafe condition to ensure a safe workplace.

　　Must comply with company health and safety procedures and policies and must immediately report any unsafe conditions Understand and comply with company environmental and health and safety policies, and procedures. Understands site objectives.

　　Any other duties commensurate with the level and scope

　　根據(jù)作業(yè)指導(dǎo)書按時(shí)完成相關(guān)微生物檢驗(yàn)：水，產(chǎn)品和工廠環(huán)境，以確保產(chǎn)品符合法規(guī)和公司標(biāo)準(zhǔn)。

　　負(fù)責(zé)標(biāo)識(shí)測試產(chǎn)品的檢驗(yàn)狀態(tài)，隔離任何不符合微生物標(biāo)準(zhǔn)的產(chǎn)品，防止不合格產(chǎn)品被使用。

　　根據(jù)作業(yè)指導(dǎo)書正確使用校準(zhǔn)設(shè)備及時(shí)測試進(jìn)貨原材料，包材，過程材料，QA放行檢驗(yàn)日常檢驗(yàn)及特殊實(shí)驗(yàn)，以確保產(chǎn)品

　　質(zhì)量符合公司的標(biāo)準(zhǔn)。

　　4.按照要求校準(zhǔn)設(shè)備，確保符合公司作業(yè)指導(dǎo)書。

　　5.及時(shí)根據(jù)實(shí)驗(yàn)結(jié)果&最終決定在SAP中放行或凍結(jié)批次。

　　6.按照需要及時(shí)準(zhǔn)備批次COA/COC。

　　7.根據(jù)需要在TW系統(tǒng)下發(fā)實(shí)驗(yàn)結(jié)果超標(biāo)的偏差。調(diào)查檢驗(yàn)結(jié)果超標(biāo)是否與樣品，設(shè)備，人員，方法等方面有關(guān)，如果發(fā)現(xiàn)檢驗(yàn)結(jié)果超標(biāo)與實(shí)驗(yàn)室有關(guān)，則需要快速采取措施。

　　8.確保所有文檔完全完成,維護(hù)實(shí)驗(yàn)室日志和記錄,以確保可追溯性。

　　9.根據(jù)需要改進(jìn)測試方法，確保及時(shí)更新質(zhì)量體系中的相關(guān)文件。

　　10.及時(shí)向?qū)嶒?yàn)室主管報(bào)告異常情況，確保及時(shí)將問題解決。

　　11.和相關(guān)部門及時(shí)溝通對(duì)檢驗(yàn)有影響的問題 (設(shè)備，環(huán)境，樣品等)。

　　12.負(fù)責(zé)進(jìn)行內(nèi)部審核，尤其是對(duì)微生物較敏感的區(qū)域。

　　13.負(fù)責(zé)培訓(xùn)微生物相關(guān)事宜以及GMP,5S, SOP等。

　　14.管理與完成微生物相關(guān)事項(xiàng)的所有資源，確保各項(xiàng)資源滿足計(jì)劃要求，并對(duì)哪些方面的資源未能達(dá)到相關(guān)要求提出建議。

　　15.持續(xù)進(jìn)行專業(yè)改進(jìn)確保保持現(xiàn)有的知識(shí)能滿足對(duì)于醫(yī)療器械的微生物要求。

　　16.在RB方法中的微生物方面進(jìn)行輸入，并向其他RB工廠學(xué)習(xí)，實(shí)施方法。

　　17.履行環(huán)保責(zé)任，例如隔離廢棄物和遵守GMPs的規(guī)定(良好的生產(chǎn)規(guī)范)，確保符合ISO 14001的要求。

　　18.必須遵守公司關(guān)于健康和安全的程序和政策，發(fā)現(xiàn)不安全因素立即報(bào)告，以確保安全的工作環(huán)境。

　　19.理解并遵守公司的環(huán)境、健康與安全政策和程序，理解工廠的相關(guān)目標(biāo)。

　　20.完成分配到的其它任務(wù)。

　　篇三

　　Our vision:

　　We strive to be the leading supplier using science and technology to improve the quality of life.

　　Our mission:

　　We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.

　　Do you want to help us as we shape the future of this great organization?

　　質(zhì)量控制分析技術(shù)員-微生物技術(shù)員

　　工作職責(zé)：

　　根據(jù)SOP和相關(guān)的測試方法完成實(shí)驗(yàn)室日常檢驗(yàn)，記錄等工作;

　　負(fù)責(zé)純化水樣品，潔凈間，氮?dú)獗O(jiān)測樣品的取樣

　　負(fù)責(zé)儀器驗(yàn)證，日常校準(zhǔn)及維護(hù)工作;

　　協(xié)助或負(fù)責(zé)實(shí)驗(yàn)室OOS，DR調(diào)查工作;

　　維護(hù)實(shí)驗(yàn)室消耗品的管理，衛(wèi)生工作以及文件管理工作;