职位详情
质量保证助理 - 知名生物制药企业
面议
应届毕业生 学历不限
职位描述
1.严格按照公司的质量体系要求工作,并不断完善质量体系。2.负责审核已执行批记录,如审核生产操作和工艺要求的一致性和符合性。3.负责生产关键日志的审核。4.协助物料处理。5.协助客户审核/检验准备工作。6.完成直线经理/主管分配的任务。1.Work strictly in accordance with the company's quality system requirements, and continueto improve the QMS .2.Responsible for review of Executed Batch Records, such as reviewing the consistency andcompliance of production operations and process requirements.3.Responsible for production critical logbook review.4.Assist in material disposition.5.Assist in customer audit/inspection preparation.6. Complete the tasks assigned by line manager/supervisor.1、生物技术、制药、制药工程等相关专业本科以上学历;。2、2年以上药品生产或质量保证工作经验,有生物治疗工作经验者优先。3、熟悉 NMPA、 EMA、 FDA 药品生产质量相关法规,有良好的 GMP 理解和执行能力。4、良好的沟通能力和团队合作精神。5、工作认真,细心,责任心强,积极主动,服从安排。6、良好的英语听说读写能力1.Bachelor degree or above in related majors such as biotechnology, pharmacy orpharmaceutical engineering.2. More than 2 years of work experience in drug production or quality assurance,biopharmaceutical work experience is preferred.3.Familiar with NMPA, EMA, FDA drug production quality related regulations, have goodunderstanding and implementation ability of GMP.4.Good communication skills and teamwork spirit.5. Working conscientiously, carefully, having strong sense of responsibility, and shall beproactive, and obey arrangements.6. Good English listening, writing and speaking skills.上班时间:8:30-12:00;13:00-17:00;周末双休,有班车接送上班地址:广州市黄埔区九佛建设路333号(龙沙生物技术有限公司)GE生物园薪资:税前7-9K,基本工资80% 绩效20%,2个试用期,试用期工资不打折 职能类别:质量管理/测试工程师(QA/QC工程师) 关键字:质量质量保证QA英文
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