工艺验证主管 苏州

月薪： 1-1.3万/月

该公司所有职位
  • 2年经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： Primary Function:1) 参与苏州工厂的固体制剂项目的生产工艺验证，清洁验证Major Responsibilities and Duties:1）参与苏州工厂的固体制剂项目的生产工艺验证，清洁验证参与制剂生产工艺验证、现场核查和清洁验证；2）参与苏州工厂的固体制剂项目的生产；3）协助应对内部或外部的 GMP 审计、检查；4） 协助新药审批、新药生产等相关工作。Qualifications:1）药剂学或相关专业毕业，本科及以上学历；2）熟悉cGMP规范，至少有2年以上的验证工作经验。曾主持或参与药品的工艺验证、清洁验证、设备的确认、环境的确认等相关工作3) 能独立实施负责的验证活动并完成验证相关文件4） 具有优良的职业道德、敬业精神及团队协作精神；工作积极主动、严谨及高效；责任心强，勇于承担责任挑战自我，具有创新精神5) 具有较强的协调、沟通及文字表达能力及组织能力。 职能类别： 生物工程/生物制药 药品生产/质量管理 关键字： 制药，工艺 验证

联系方式

桑田街218号生物产业园8栋

公司信息

ZAI Lab is a leading biotech company based in China focused on discovering and developing innovative medicines for unmet medical needs globally. The company is building a strong portfolio of therapeutic programs aimed at transforming patients’ lives. Zai Lab has a world class leadership team with deep experience at global pharmaceutical and biotech organizations. The team has a strong track record of success – successfully taken five novel drug candidates into clinical trials in China, pioneered new regulatory channels, secured regulatory approvals in record times, conducted multiple IND trials in the US, and brought the first China discovered drug into Global Phase III trials. Zai Lab is committed to build a globally leading drug research and development powerhouse with a culture of excellence and teamwork and a strong focus on fostering innovation and creativity. For more information, please visit www.zailaboratory.com.

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