工作內(nèi)容CONTENT 1.壓縮空氣系統(tǒng)包括儀表壓縮空氣系統(tǒng)和潔凈壓縮空氣系統(tǒng)和氮?dú)庀到y(tǒng)。The compressed air system includes compressed air system and clean compressed air system and nitrogen system. 2.負(fù)責(zé)編寫壓縮空氣系統(tǒng)相關(guān)用戶需求標(biāo)準(zhǔn)(URS),提出設(shè)備采購申請(qǐng)。Responsible for drafting CA User Requirement Specification (URS) and proposing the application for equipment purchasing. 3.負(fù)責(zé)壓縮空氣系統(tǒng)設(shè)備驗(yàn)收,并撰寫設(shè)備相關(guān)操作和維護(hù)SOP。Responsible for CA equipment acceptance and preparing SOPs related equipment operation and maintenance. 4.負(fù)責(zé)監(jiān)督壓縮空氣系統(tǒng)施工質(zhì)量,安裝調(diào)試期間協(xié)調(diào)。Responsible for supervising the construction quality of CA and coordinating during installation and commissioning. 5.負(fù)責(zé)壓縮空氣系統(tǒng)設(shè)備預(yù)防性維護(hù)保養(yǎng)計(jì)劃的制定和實(shí)施。Responsible for making and implementation CA equipment preventive maintenance plans. 6.負(fù)責(zé)壓縮空氣系統(tǒng)設(shè)備全生命周期管理,包括采購、調(diào)試、服役、退役。Responsible for the whole life cycle management of CA equipment, including procurement, commissioning, service and decommissioning. 7.負(fù)責(zé)壓縮空氣系統(tǒng)設(shè)備日常操作、維修。Responsible for CA equipment daily operations and maintenance and scrapping of equipment. 8.負(fù)責(zé)壓縮空氣系統(tǒng)設(shè)備技術(shù)檔案的收集及管理。Responsible for collecting and managing CA equipment technical files. 9.負(fù)責(zé)建立壓縮空氣系統(tǒng)設(shè)備/儀表臺(tái)賬。Responsible for setting up CA equipment/instrument list. 10.負(fù)責(zé)壓縮空氣系統(tǒng)設(shè)備備品備件的選購。Responsible for selective purchasing CA equipment spare parts. 11.負(fù)責(zé)壓縮空氣系統(tǒng)設(shè)備突發(fā)問題的協(xié)調(diào)和解決。Responsible for coordinating and solving CA equipment emergent problems. 12.完成壓縮空氣系統(tǒng)變更、偏差調(diào)查和評(píng)估,并上報(bào)QA。Complete CA change and deviation investigation and evaluation, and report to QA. 13.對(duì)設(shè)備和廠房的變更做出評(píng)估。Evaluate the changes of equipment and workshop. 14.配合完成第三方和客戶審計(jì)和參觀等事情。Cooperate with third party and customer audits and visits. 15.完成其他相關(guān)工作。Execute other related tasks.
教育背景和任職資格EDUCATION BACKGROUND and QUALIFICATION 1.藥學(xué)、機(jī)電、機(jī)械或其他相關(guān)專業(yè)本科及以上學(xué)歷。College degree or above in pharmaceutical, electromechanical, mechanical or other related majors. 2.兩年以上制藥或相關(guān)行業(yè)設(shè)施安裝、維修及保養(yǎng)工作經(jīng)驗(yàn)。More than 2 years’ experience in equipment installation, repair and maintenance in pharmaceutical or related industries. 3.熟悉藥品質(zhì)量規(guī)范和GMP標(biāo)準(zhǔn)。Familiar with drug quality specifications and GMP standards. 4.具備壓縮空氣系統(tǒng)驗(yàn)證及相關(guān)工作經(jīng)驗(yàn)。Have the experience in CA validation and related work. 5.具備專業(yè)技術(shù)能力,具備專業(yè)的機(jī)械設(shè)備安裝、維修以及保養(yǎng)知識(shí),具備熟練的設(shè)備維修及保養(yǎng)操作技能。Have professional technical ability, have professional knowledge of mechanical equipment installation, repair and maintenance, and have skillful operational skills of equipment repair and maintenance. 6.具備較強(qiáng)的問題分析、判斷及解決能力。Have strong ability of problem analysis, judgment and resolution. 7.具備良好的溝通交流能力。Have good communication ability. 8.熟練使用Office、CAD等辦公軟件。Skilled in Office, CAD, and other office software. 9.具備一定的英語讀寫能力。Have Good English reading and writing skills.