本岗位需要倒班,四班两倒,12小时制(早休夜休) 主要责任 Key responsibilities 61 执行物料的取样,包括原料、包装材料、最终产品等。 Perform sampling of materials, including raw materials, package materials and final products. 61 负责仓库取样间以及取样工具的日常管理。 Responsible for the routine management of sampling room in warehouse and sampling tools. 61 参与实验室的专项管理工作,如对照品、剧毒化学试剂、取样、留样等。 Participate certain lab management work, e.g.: reference standard, highly toxic reagents, sampling, retain sample; 61 根据标准作业程序进行样品测试,包括原料,IPC,中间体,API等。 Carry out sample testing according to the SOPs,including raw material, IPC,Intermediate, API. 61 起草分析报告单或分析证书。 Compile analytical reports or CoAs; 61 参与QC人员培训。 Participate in QC personals training; 61 参与新项目的转移,如原料的筛选、分析方法的确认与转移等。 Participate in new projects transfer, e.g.: raw material selection, and method verification and transfer; 61 起草质量规格和分析方法程序。 Draft specifications and analytical procedures; 61 参与OOS,OOT和偏差的调查。 Participate in the investigation of OOS, OOT and deviation; 61 配合主管做好现场审计工作。 Cooperate with supervision to complete work of authority/ clients audits. 主要经验和技能 Critical Experience and Skills 61 药物或化学或仪器分析或类似的背景优先(大专或以上)。 Pharmaceutical or Chemical or Instrument analysis or similar background is preferred (college or above). 61 原料药厂工作经验优先。 Experience in API Factory is preferred. 61 具有色谱分析或光谱分析或粒径分析或电位滴定等仪器分析或常规理化分析相关经验,或具有微生物分析经验。 Have solid experience in instrumental analysis, e.g. Chromatograph analysis, or Spectrometry analysis or Particle Size analysis or potentiometric titration, or Wet chemistry analysis, or Microbial analysis experience. 61 具有药品GMP的相关知识,如cGMP,EU-GMP,中国GMP等,以及实际应用经验。 Have Drug GMP relevant knowledge and practical implementation experience, e.g. cGMP, EU-GMP, State GMP. 61 了解药典,如美国药典、欧洲药典、中国药典等。 Have knowledge on Pharmacopeias, e.g. USP, EP, CP. 61 良好的英语说和写的能力。 Good oral and written English skill.