職位描述
1.TO CARRY OUT ANALYTICAL TESTING OF API, RAW MATERIALS, ACTIVE INGREDIENTS, PACKAGING MATERIALS, IN PROCESS SAMPLES, INTERMEDIATES, AND FINISHED PRODUCTS,CCORDING TO THE TEST METHODS AND MEDICAL DEVICE REQUIREMENTS.
-按照分析方法及醫(yī)療器械的要求進(jìn)行原輔料、包材、中控樣品以及成品的檢驗(yàn)
2.ENSURE THAT ANALYSES ARE CARRIED OUT ON TIME AND ARE IN COMPLIANCE WITH THE SPECIFICATIONS. PARTICIPATE TO THE OOS INVESTIGATIONS AND THE QUALITY ASSESSMENT.
確保樣品及時(shí)檢驗(yàn)并符合質(zhì)量標(biāo)準(zhǔn)的要求。參與超標(biāo)結(jié)果的調(diào)查以及產(chǎn)品質(zhì)量評(píng)估
3.PERFORM THE SAMPLING OF RAW MATERIALS, ACTIVE INGREDIENTS, PACKAGING MATERIALS, IN PROCESS SAMPLES, INTERMEDIATES, AND FINISHED PRODUCTS.
負(fù)責(zé)原料、輔料、包裝材料、中間制程產(chǎn)品、中間體及成品的取樣
4.PERFORM ANALYTICAL TRANSFERRING / VALIDATION AND THE PREPARING OF STABILITY TEST PROTOCOL AND REPORTS FOR THE NEW PRODUCTS.
分析方法轉(zhuǎn)移及驗(yàn)證，為新產(chǎn)品準(zhǔn)備穩(wěn)定性試驗(yàn)方案
5.MAINTAIN THE AVAILABILITY OF TEST EQUIPMENT TOGETHER WITH SUPPLIER AND MAINTENANCE TECHNICIAN.
與設(shè)備廠家及維護(hù)工程師一起確保檢驗(yàn)設(shè)備的正常狀態(tài)
6.CARRY OUT THE MAINTENANCE/CALIBRATION OF LABORATORY EQUIPMENT IN COMPLIANCE WITH THE ESTABLISHED SCHEDULES AND MAINTAIN ACCURATE RECORDS AND DOCUMENTATION OF THE MAINTENANCE/CALIBRATION.
按計(jì)劃對(duì)實(shí)驗(yàn)室儀器進(jìn)行維護(hù)、校準(zhǔn)并準(zhǔn)確記錄和存檔
7.ASSIST THE SUPERVISOR BY WRITING DRAFT SOPS, DRAFT QUALIFICATION PROTOCOLS OF THE ANALYTICAL INSTRUMENTS AND THE ANALYTICAL METHODS. PERFORM THE QUALIFICATION WORK.
協(xié)助主管編寫標(biāo)準(zhǔn)操作規(guī)程、儀器確認(rèn)方案及分析方法。進(jìn)行驗(yàn)證工作
7.GAP ANALYS FOR GLOBAL REQUIREMENT AND LOCAL AUTHORITY STANDARD.
總部要求及本地法規(guī)標(biāo)準(zhǔn)的差距分析。
8.TO BE THE BACK UP OF THE OTHER ANALYST/S.
其它分析員缺席時(shí)，作為替補(bǔ)。
9. ENGAED IN THE LAB CONTINUOUSELY IMPROVEMENT FOR TECHNICAL AND MANAGEMENT PERPURSE. ADVOCATE AND EXECUTE THE SMS CONCEPT AND PRACTICE.
參與實(shí)驗(yàn)室管理及技術(shù)的持續(xù)改善活動(dòng)。倡導(dǎo)和實(shí)施賽諾菲管理系統(tǒng)。
10.HSE RESPONSIBILITY: ACTIVELY INVOLVED IN THE HSE RISK ASSESSMENT, REPORT RELATIVE RISKS/EVENTS/ACCIDENTS TO SECTION HEAD. PARTICIPATE IN THE HSE INVESTIGATION. PROPERLY USE PERSONAL PROTECTIVE EQUIPMENT. COMMITMENT TO SAVING ENERGY AND NATURAL RESOURCES, WASTE SEPARATION AND OTHER ENVIRONMENTAL PROTECTION ACTIVITIES.
健康安全環(huán)境職責(zé)：按照相關(guān)的HSE要求進(jìn)行工作，確保符合環(huán)境/安全/健康的要求。積極參與環(huán)境與安全的風(fēng)險(xiǎn)評(píng)估工作。及時(shí)向部門負(fù)責(zé)人報(bào)告環(huán)境與安全風(fēng)險(xiǎn)或相關(guān)事件/事故。參與公司的環(huán)境與安全事件的調(diào)查工作。正確使用有用的，必要的個(gè)人防護(hù)用品。致力于節(jié)約能源和自然資源，垃圾分類等環(huán)保行為。
REQUIREMENTS
Education /
職位要求：
Experience
A BACHELOR DEGREE IN CHEMISTRY, PHARMACY OR RELATIVE MAJORS.
化學(xué)、制藥或相關(guān)專業(yè)學(xué)士學(xué)位。
EXPERIENCE IN PHARMACEUTICAL OR MEDICAL DEVICE ENVIRONMENT IS PREFERRED.
具備藥廠或醫(yī)療器械領(lǐng)域相關(guān)工作經(jīng)驗(yàn)者優(yōu)先考慮。
Technical skills &
Competencies / Language
HANDS-ON EXPERIENCE IN ANALYTICAL EQUIPMENT, E.G. HPLC, GC, UV, AND FTIR. MUST BE ANALYTICAL, METHODICAL AND QUALITY ORIENTED. THE KNOWLEDGE OF CHINESE AND INTERNATIONAL GMP ON MEDICINAL PRODUCTS OR MEDICAL DEVICE IS PREFERABLE. ENGLISH PROFICIENCY BOTH WRITTEN AND SPOKEN.
具有HPLC, GC, UV, 和 FTIR等分析儀器的操作經(jīng)驗(yàn)。具有分析、方法學(xué)及質(zhì)量意識(shí)。熟悉中國(guó)及國(guó)際藥品或醫(yī)療器械GMP要求者優(yōu)先。英文讀寫及口語(yǔ)流利。
