• 5-7年经验
  • 招1人
  • 英语良好
  • 11-09 发布

职位描述

职位描述: 工作内容: 1. 作为质量部现场管理人员,及时收集处理以及反馈产品、物料的相关信息,并对生产活动的合规性给出指导。 2. Representative as quality assurance for shop floor management, collect, handling and feedback product/material related issue with timely manner, ensure the operations of shop floor and warehouse compliance with cGMP. 3. 负责所有生产区的日常操作的合规性,含原液车间、灌装、包装以及取样管理等; Ensure the compliance of the manufacturing activities for all production areas, e.g. Drug substance manufacturing, Filling, Packaging and sampling management; 4. 负责工厂物料控制系统的维护,建立物料表现数据库, 及时建立物料供应商投诉记录, 跟进供应商问题的调查, 确保物料整个使用周期内的合规性; Responsible for maintain and optimize the site material control system, establish material performance database, document material complaints in a timely manner, follow up on supplier investigation progress, to ensure the compliance of material in the whole lifecycle; 5. 车间操作类文件审核以确保有恰当的细节和说明来指导车间的生产活动; Review manufacturing processes related documentation (e.g. work instruction) to ensure the appropriate details are adequately guide the shop floor execution; 6. 协调工厂偏差调查、制定相应CAPA,以及CAPA的实施和有效性核查。 Coordinate non-conformance investigation and CAPA initiation; monitoring CAPA implementation and perform effectiveness check. 任职要求: 教育程度/经验 Education/Experiences - 生物技术、微生物、生化或制药等相关专业本科及以上,或有相关教育背景; Bachelor’s Degree or above in the field of Microbiology, Biotechnology, Biochemistry, Pharmacy or other appropriate education; 特别知识/技能 Specific Knowledge & Skills - 5年及以上生物技术及制药行业工作经验,熟悉制药相关法规GMP等; 5 years and experience in biotech or pharmaceutical industry,Familiar with pharma related Regulations GMPs; I would Recommend to say: 5 years working experience in Biologics, but at least 3 year in Quality Assurance. - 英语口语及书面语流利,良好的沟通能力。 Have excellent written and spoken English. Good communication skills. 职能类别: 其他

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公司信息

辉瑞公司(Pfizer Inc.)创建于1849年,迄今已有160多年的历史,总部位于美国纽约,是目前全球最大的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。 我们的目标是“ ”。我们的使命是“ ”。 2012年辉瑞公司全年合计收入590亿美元,研发投入78亿美元。辉瑞在全球拥有9万多名员工,59家生产基地,业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。 目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域,同时其卓越的研发和生产能力处于全球领先地位。 在人类和动物药品的发现、开发和生产过程中,辉瑞始终致力于奉行严格的质量、安全和价值标准。每天,分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。 辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作,支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来,辉瑞一直努力为人们提供更好、更优质的服务。 辉瑞生物制药目前在华上市的创新药物已超过50个,其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗,辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。 辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓,并以其优异的品质深受广大消费者的青睐;辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。 At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.

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