杭州招聘

1.1 遵守公司规章制度；

Obey the company regulations;

1.2 负责QA-SH部门相关文件的起草，修订和审核；

Be responsible for initiating, revising, reviewing SOPs related to QA-SH

1.3 负责审核偏差、变更、CAPA、OOS/OOT、实验室调查；

Be responsible for reviewing deviation, change control, CAPA, OOS/OOT, laboratory investigation;

1.4 负责检验记录，方法验证记录等的审核；

Be responsible for reviewing of analysis record, method validation record and other record in QC-SH;

1.5 负责电子数据的审核工作；

Be responsible for reviewing electronic data;

1.6 协助公司合规工作，参与部门内部合规检查；

Be responsible for coordinating compliance audit from company and internal compliance check;

1.7 定期向直接上级汇报工作；

Report to supervisor of the job periodically;

1.8 完成上级领导交办的其他工作.

Finish the other jobs assigned by supervisor.

任职资格

1.1 具备医药或相关专业大专以上教育背景；

With the education background of medicine or relevant major of junior college or above;

1.2 熟悉GMP/cGMP/欧盟GMP等法规；

familiar with the GMP/cGMP/EU GMP regulations;

1.3 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);

1.4 熟悉统计软件的使用；

Familiar with the usage of statistical software;

1.5 英语读写能力良好。

With good English reading and writing ability.

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