？ 1.?Degree?or?diploma?大學(xué)或大專以上學(xué)歷
？ 2.?At?least?2?year?experience?in?Micro?lab?as?lab?technician?or?supervisor.?至少有兩年以上微生物實(shí)驗(yàn)技術(shù)員或主管經(jīng)驗(yàn)。??無(wú)菌理化
？ 3.?Major?in?Pharmacy,?Pharmaceutical?Engineering?or?Microbiology?制藥?/?制藥工程?/?微生物學(xué)專業(yè)
Job?scope:
1.Creation?and?development?of?technical?documentation?as?well?as?the?management?and?control?of?a?corporate?Quality?documentation?system,?including?the?documents,?records?and?associated?processes.
建立并發(fā)展質(zhì)量體系文件及技術(shù)文檔,包括各相關(guān)過(guò)程的文檔和記錄
2.Review?and?distribute?the?new/revised?document?as?per?document?change?request.
審核并分發(fā)文件變更記錄所要求的新文件或修改的文件
3.Establishes?and?maintains?a?central?repository,?including?history?files,?for?all?controlled?Quality?&?Regulatory?documents?and?records.
建立并維護(hù)中心文檔,包括質(zhì)量及法規(guī)的所有文檔記錄
4.Perform?various?duties?essential?to?the?implementation?and?maintenance?of?a?regulated?documentation?system,?including?coordinating?efforts?for?the?control?of?new?and?updated?Quality?System?procedures?for?ISO/QSR.
承擔(dān)實(shí)施及維護(hù)法規(guī)體系文件的職責(zé),包括根據(jù)ISO/QSR要求新建和更新程序文件
5.Ensure?the?consistency?and?quality?system?of?Medical?Device?product,?process,?and?policy?documentation.
確保質(zhì)量體系的產(chǎn)品,過(guò)程,程序文件一致性
6.Clean?room?monitoring?monthly?and?data?analysis.
潔凈室月度監(jiān)控和數(shù)據(jù)分析
7.Follow?up?the?internal?audit?and?external?audit?findings?to?ensure?the?closure?timely.
跟進(jìn)內(nèi)審/外審的發(fā)現(xiàn),確保及時(shí)關(guān)閉
8.Responsible?for?NEO?Induction?Training.
負(fù)責(zé)入職培訓(xùn)(質(zhì)量部分)
9.In-charge?of?review?the?DHR?and?batch?record.
負(fù)責(zé)評(píng)審DHR及批記錄
10?Support?QA?Dept.?for?the?daily?grind,?including?office?supply?requisition?and?checking?attendance?each?month?by?system.
支持QA部門(mén)的日常事務(wù),包含日用品的采購(gòu),檢查每月的出勤
11.Review?of?Sterilization?report?and?certificate;?Issue?COC?for?outgoing?goods.
審核滅菌報(bào)告,完成成品出貨COC
12.Supervise?and?coordinate?with?Micro?lab?technician?for?Micro?lab?daily?operations.
管理并協(xié)助微生物技術(shù)員負(fù)責(zé)微生物實(shí)驗(yàn)室的日常運(yùn)行