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.
-按照分析方法及醫療器械的要求進行原輔料、包材、中控樣品以及成品的檢驗
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.
確保樣品及時檢驗并符合質量標準的要求。參與超標結果的調查以及產品質量評估
3.PERFORM THE SAMPLING OF RAW MATERIALS, ACTIVE INGREDIENTS, PACKAGING MATERIALS, IN PROCESS SAMPLES, INTERMEDIATES, AND FINISHED PRODUCTS.
負責原料、輔料、包裝材料、中間制程產品、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.
分析方法轉移及驗證，為新產品準備穩定性試驗方案
5.MAINTAIN THE AVAILABILITY OF TEST EQUIPMENT TOGETHER WITH SUPPLIER AND MAINTENANCE TECHNICIAN.
與設備廠家及維護工程師一起確保檢驗設備的正常狀態
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.
按計劃對實驗室儀器進行維護、校準并準確記錄和存檔
7.ASSIST THE SUPERVISOR BY WRITING DRAFT SOPS, DRAFT QUALIFICATION PROTOCOLS OF THE ANALYTICAL INSTRUMENTS AND THE ANALYTICAL METHODS. PERFORM THE QUALIFICATION WORK.
協助主管編寫標準操作規程、儀器確認方案及分析方法。進行驗證工作
7.GAP ANALYS FOR GLOBAL REQUIREMENT AND LOCAL AUTHORITY STANDARD.
總部要求及本地法規標準的差距分析。
8.TO BE THE BACK UP OF THE OTHER ANALYST/S.
其它分析員缺席時，作為替補。
9. ENGAED IN THE LAB CONTINUOUSELY IMPROVEMENT FOR TECHNICAL AND MANAGEMENT PERPURSE. ADVOCATE AND EXECUTE THE SMS CONCEPT AND PRACTICE.
參與實驗室管理及技術的持續改善活動。倡導和實施賽諾菲管理系統。
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.
健康安全環境職責：按照相關的HSE要求進行工作，確保符合環境/安全/健康的要求。積極參與環境與安全的風險評估工作。及時向部門負責人報告環境與安全風險或相關事件/事故。參與公司的環境與安全事件的調查工作。正確使用有用的，必要的個人防護用品。致力于節約能源和自然資源，垃圾分類等環保行為。
REQUIREMENTS
Education /
職位要求：
Experience
A BACHELOR DEGREE IN CHEMISTRY, PHARMACY OR RELATIVE MAJORS.
化學、制藥或相關專業學士學位。
EXPERIENCE IN PHARMACEUTICAL OR MEDICAL DEVICE ENVIRONMENT IS PREFERRED.
具備藥廠或醫療器械領域相關工作經驗者優先考慮。
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驗。具有分析、方法學及質量意識。熟悉中國及國際藥品或醫療器械GMP要求者優先。英文讀寫及口語流利。
