岗位职责 Responsibility
1. 负责原辅料、包装材料及成品取样、检验。 Responsible forsampling, inspection of raw materials, packaging materials and final products.
2. 独立录入电子数据并出具相关检验报告,确保检验报告的真实有效。Input electronic data independently and issue relevant inspection reports. Ensure the inspection reports are true and valid.
3. 协助上司进行质量偏差调查Assist the supervisor in quality deviation investigation
4. 执行实验室日常检验工作(理化),支持工艺用水及厂房环境的月度检测和监测工作 Perform dailylaboratory inspection (physicochemical), support the monthly inspection and monitoring of process water and plant environment
5. 协助对实验室相关的检验仪器进行管理,校正和维护,确保检验仪器可支持实验室检验工作以及相关检验数据的有效性。Assist in the management, calibration and maintenance of laboratory related inspection instruments. Ensure that the test equipment can support the laboratoryinspection task and the validity of the relevant test data.
6. 协助产品外部检验的送检,报告整理归档Assist product external inspection submission, report filing
Medical Technology
7. 协助实验室检验试剂,耗材的管理,包括采购,入库和定期盘点,保证足够的实验用试剂及耗材可支持到实验室检验工作。Assist lab in the management of test reagents and consumables, including purchasing, warehousing and regular inventory, to ensure adequate test reagents andconsumables for laboratory testing.
8. 协助工程师进行检验仪器和测试方法的验证Assist engineer to validate test instrument and test method
9. 协助相关OOS/OOT的调查过程,并完成调查报告Assist in OOS/OOT investigation process and complete investigation report
10. 完成上司交代的其它工作任务Complete other tasks assigned by superior
任职资格 Qualification
◆中专及以上,化学类、化工类、制药、生物工程、机械相关专业
Senior college or above,Chemistry, chemical engineering, pharmaceutical,biological engineering, machinery or related major
◆ 熟练掌握医疗器械化学检验操作,熟练使用和维护常规理化检验设备(如GC/HPLC/酶标仪等)Good at the chemical inspection of medical equipment, familiar with the use and maintenance of routine physical and chemical inspection equipment (suchas GC/HPLC/ elisa machine, etc.)
◆ 熟练掌握医疗器械化学检验标准,如GB/T14233,药典Good command of chemical inspection standards for medical devices, such as GB/T14233, pharmacopoeia
◆ 熟悉医疗器械化学检验方法,如TOC、工艺用水全性能Familiar with chemical test methods of medical devices, such as TOC, process water integrity
◆ 熟悉使用WORD、EXCEL等办公软件Familiar with OFFICE software such as WORD, EXCEL.
◆ 良好个人卫生习惯Good personal hygiene
◆ 能严格遵守公司洁净车间及实验室行为管理规范Can strictly abide by the company clean workshop and laboratory behavior management code
◆ 具有良好的沟通协调能力Good communication and coordination skills
◆ 细致严谨、较强的责任心 Meticulous and rigorous, strong sense of responsibility
◆ 快速学习能力、团队合作精神Quick learning ability and team work spirit