职位描述
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.
-按照分析方法及医疗器械的要求进行原辅料、包材、中控样品以及成品的检验
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.
确保样品及时检验并符合质量标准的要求。参与超标结果的调查以及产品质量评估
3.PERFORM THE SAMPLING OF RAW MATERIALS, ACTIVE INGREDIENTS, PACKAGING MATERIALS, IN PROCESS SAMPLES, INTERMEDIATES, AND FINISHED PRODUCTS.
负责原料、辅料、包装材料、中间制程产品、中间体及成品的取样
4.PERFORM ANALYTICAL TRANSFERRING / VALIDATION AND THE PREPARING OF STABILITY TEST PROTOCOL AND REPORTS FOR THE NEW PRODUCTS.
分析方法转移及验证，为新产品准备稳定性试验方案
5.MAINTAIN THE AVAILABILITY OF TEST EQUIPMENT TOGETHER WITH SUPPLIER AND MAINTENANCE TECHNICIAN.
与设备厂家及维护工程师一起确保检验设备的正常状态
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.
按计划对实验室仪器进行维护、校准并准确记录和存档
7.ASSIST THE SUPERVISOR BY WRITING DRAFT SOPS, DRAFT QUALIFICATION PROTOCOLS OF THE ANALYTICAL INSTRUMENTS AND THE ANALYTICAL METHODS. PERFORM THE QUALIFICATION WORK.
协助主管编写标准操作规程、仪器确认方案及分析方法。进行验证工作
7.GAP ANALYS FOR GLOBAL REQUIREMENT AND LOCAL AUTHORITY STANDARD.
总部要求及本地法规标准的差距分析。
8.TO BE THE BACK UP OF THE OTHER ANALYST/S.
其它分析员缺席时，作为替补。
9. ENGAED IN THE LAB CONTINUOUSELY IMPROVEMENT FOR TECHNICAL AND MANAGEMENT PERPURSE. ADVOCATE AND EXECUTE THE SMS CONCEPT AND PRACTICE.
参与实验室管理及技术的持续改善活动。倡导和实施赛诺菲管理系统。
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.
健康安全环境职责：按照相关的HSE要求进行工作，确保符合环境/安全/健康的要求。积极参与环境与安全的风险评估工作。及时向部门负责人报告环境与安全风险或相关事件/事故。参与公司的环境与安全事件的调查工作。正确使用有用的，必要的个人防护用品。致力于节约能源和自然资源，垃圾分类等环保行为。
REQUIREMENTS
Education /
职位要求：
Experience
A BACHELOR DEGREE IN CHEMISTRY, PHARMACY OR RELATIVE MAJORS.
化学、制药或相关专业学士学位。
EXPERIENCE IN PHARMACEUTICAL OR MEDICAL DEVICE ENVIRONMENT IS PREFERRED.
具备药厂或医疗器械领域相关工作经验者优先考虑。
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等分析仪器的操作经验。具有分析、方法学及质量意识。熟悉中国及国际药品或医疗器械GMP要求者优先。英文读写及口语流利。
