杭州招聘

工作职责:

2.1 参与验证计划/验证主计划的制定；

Participate in the setting up of validation plan/ validation master plan;

2.2 负责审核验证方案和各类验证报告；

Be responsible for the reviewing of validation protocol and validation report;

2.3 负责跟踪日常及项目的验证实施过程；

Be responsible for tracking the process of validation implementation in Routine Operation/Project;

2.4 负责验证过程中的变更审核及偏差处理结果的确认；

Be responsible for the reviewing of change of validation process and verification of deviation handling result;

2.5 负责日常运行过程中再验证&工程部&QC&工艺设备的变更，偏差，CAPA的审核和批准

Be responsible for the reviewing and approving Change, Deviation, CAPA triggered by Re-validation & ENG & QC & Process System/Equipment in routine operation.

2.6 参加内审和外审相关工作；

Participate in internal and external audit;

任职资格:

3.1 具备医药或相关专业本科或以上教育背景，从事相关工作5-8年以上，熟悉GMP/cGMP/欧盟GMP等法规；

With the education background of medicine or relevant major of bachelor or above, with more than 5-8 years related working experience, familiar with the GMP/cGMP/EU GMP regulations;

3.2 有外资制药企业QA/验证/工程部工作背景者，优先考虑

Priority is given to those working in QA/Validation/ENG department in foreign pharmaceutical companies.

3.3 英语口语，读写能力良好。

With good English Speaking, reading and writing ability.

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