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Shanghai, Shanghai, CN
第一三共
QC理化分析员
Shanghai, Shanghai, CN
1 day ago
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Summary
该职位来源于猎聘 职责描述: 1、在工作中贯彻公司和法规要求,推动GMP在QC的执行和提高;
2、执行上级安排的分析任务,操作HPLC、GC、UV、IR等仪器,在合理的周期开具分析报告,优化工作效率,确保工作安全;
3、工作中严格按照SOP操作,确保分析结果的正确性和合规性,及时做好记录和开具报告,有偏差或OOS时及时报告上级并积极进行调查;
4、起草检验原始记录、检验报告等各种文件,确保QC质量体系符合法规要求;
5、保证分管的实验室管理工作及时、准确完成,如仪器管理、对照品、试剂、耗材的库存管理等,为分析工作提供保障;
6、积极参加各种培训及年度考核,确保业务水平合格。
7、起草、参加各项方法学验证和确认以及设备的校准和维护工作;
8、向上级报告QC工作中的风险识别并执行整改措施;
9、及时完成上级交与的临时性任务。 任职要求: 1、大专或以上学历,药学、化学、药物分析或相关专业;
2、3年以上药品检验经验,熟悉HPLC、GC等分析仪器;
3、基本的英语听、说、读、写能力,能阅读英文药典。
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