杭州招聘

1.工作内容

1.1 遵守公司规章制度；Obey the company regulations;

1.2 负责原液生产和细胞建库的生产的现场日常监控管理工作；Be responsible for daily on-site audit for manufacture in DS/CB

1.3 负责原液生产和细胞建库相关SOP质量文件的审核Be responsible for reviewing the quality SOPs related of DS/CB

1.4 负责原液生产和细胞建库放行管理工作；Be responsible for release manage of DS/CB

1.5 负责建立和维护原液生产和细胞建库 现场QA团队Be responsible for building and maintaining the team of DS/CB

1.6 负责原液生产和细胞建库相关的偏差，变更的审批工作Be responsible for reviewing deviations, change controls, in DS/CB

1.7 建立原液生产和细胞建库电子数据审核程序Be responsible for establishing the procedure for electronic data

1.8 负责协调原液生产和细胞建库相关的审计工作Be responsible for coordinating audit work related to DS/CB

1.9 参与原液生产和细胞建库项目管理工作Be responsible for project manage work related to DS/CB

1.10 定期向直接上级汇报工作；Report to supervisor of the job periodically;

1.11 完成上级领导交办的其他工作.Finish the other jobs assigned by supervisor.

2. 人员资质 PERSONAL QUALIFICATION

1.1 具备医药或相关专业本科以上教育背景；

With the education background of medicine or relevant major of bachelor or above;

1.2 熟悉GMP/cGMP/欧盟GMP等法规；

familiar with the GMP/cGMP/EU GMP regulations;

1.3 具备生产，检验，物料管理等相关工作经验

Manage experience with manufacture, analysis, materials is preferred;

1.4 5年以上QA工作经验，至少1年QA管理经验；

Five years QA experience with at least one years QA manage experience is preferred;

1.5 上岗前各项考核（健康状况、培训）合格；

Pass the all examinations before onto job (healthy situation, training);

1.6 良好的沟通协调能力，以及良好的团队建设和管理能力。

With good communication ability，team building and manage ability.

3.7 良好的英文听说读写能力。

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