高级质量保证专员, 佛山 job opportunity at Air Liquide.

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DateMore Than 30 Days Ago bot
Air Liquide 高级质量保证专员, 佛山
Experience: General
Pattern: full-time
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佛山

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loacation PAG Kodi - Industrial spec gas, China
loacation PAG Kodi - Ind..........China

液化空气集团早在1916年就进入中国，70年代开始向中国提供空分设备，经过多年的稳步发展，目前在中国设有近120家工厂，遍布40多个城市，拥有约5000名员工。集团在华主要经营范围包括工业及医用气体的运营，家庭健康服务，工程与制造业务，以及全球市场与技术和上海创新园从事的创新业务。公司业务已覆盖中国主要的沿海工业区域，并继续向中部、南部和西部地区拓展。 液化空气通过创造卓越绩效和履行责任追求盈利性增长和长期可持续发展，并保持在中国的行业领先地位。依托于集团的长期战略与全球资源，公司聚焦能源、环境、高科技和健康等领域，以迎接挑战并创造新的市场机遇。凭借专业团队的全力支持，公司致力于为客户提供可信赖的服务与高附加值解决方案，同时履行企业社会责任。 本职位主要负责确保所有药品生产、检验及放行活动严格符合中国GMP及公司内部质量管理体系的要求，以保证产品质量和患者安全。 您将如何贡献和成长？ 协助搭建工厂的质量管理体系、与团队共同完成生产、分析方法的验证，确保新产品生产线通过药监局的上市许可现场检查。 在上市许可申请前，识别现有流程中的差距和改进机会，并牵头进行相关SOP的修订，持续优化和维护质量管理体系。 熟悉药品生产质量管理规范及相关法规，能够熟练运用 GMP 要求对生产现场进行监督检查。 协助配合实施公司内、外部审计，撰写整改报告并跟踪整改项的落实。 组织GMP法规及质量体系培训。 您是合适的人选么？ 出色学习能力，分析和解决问题的能力。 良好的沟通、表达和人际交往能力 团队合作能力 能够独立开展工作，严谨的工作态度。 本科及以上学历，制药、药学、化学相关专业 3年及以上在制药行业的QA工作经验，有ANDA注册现场核查和GMP符合性检查经验优先 有良好的GMP知识，熟悉药品相关法律法规和药品质量体系管理  有应对药监部门现场检查和对外沟通的经验 关于液化空气集团 液化空气集团 —— 全球工业与健康领域气体、技术和服务的领导者，业务遍及78个国家/地区，员工约64,500 人，为380多万名客户与患者提供服务。氧气、氮气和氢气是生命、物质及能源不可或缺的小分子。它们象征着液化空气的科学疆域，自集团1902年成立以来，始终位于其业务的核心。 多样化造就了我们的业绩 在液化空气，我们致力于建立一个多元化和包容性的工作场所，拥抱来自全球的员工、客户、患者、社区利益相关者和文化的多样性。 我们欢迎并考虑所有合格申请人的申请，无论他们的背景如何。我们坚信，多元化的组织为人们提供了展示个人和集体才能的机会，它有助于培养我们的创新能力，通过践行我们的基本原则、为我们的成功而努力并在不断变化的世界中创造一个有吸引力的环境。

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