杭州招聘

1.1 负责建立并维护公司质量体系，包括偏差、变更、投诉与不良反应、召回、产品回顾、风险管理等子系统；

Responsible for establishing and maintaining the quality system of the company, including the subsystems of deviation, alteration, complaint and adverse reaction, recall, product review and risk management;

1.2 负责药品不良反应报告审核，组织质量有关的药品不良反应调查，并报告至国家药品不良反应监测系统；

Responsible for the audit of ADR reports, organizing quality-related ADR investigations and reporting to the national ADR monitoring system;

1.3 负责产品召回的管理，并定期进行模拟召回，确保召回体系有效性；

Responsible for the management of product recall, and carry out the simulation recall regularly to ensure the validity of the recall system;

1.4 负责对质量体系不良反应文件进行起草、修订；

Responsible for drafting and revising the quality system adverse reaction documents.

任职资格

1.1 具备医药或相关专业本科以上教育背景，从事相关工作3年以上，且熟悉产品召回、退回、资料申报等工作；

With a master's degree or above in medicine or related fields, he has been engaged in related work for more than eight years and is familiar with the work of product recall, return and data declaration With a master's degree or above in medicine or related fields, he has been engaged in related work for more than eight years and is familiar with the work of product recall, return and data declaration;

1.2 参与过FDA 、CFDA审计工作；有相关国内外FDA、CFDA审计经验，协助取得GMP相关认证；

Participated in the audit of FDA and cfda; Relevant domestic and foreign FDA and cfda audit experience to assist in obtaining GMP related certification;

1.3 良好英语听说读写能力，熟练使用计算机办公软件；

Good English listening, speaking, reading and writing skills, good use of computer office software;

1.4 有较强分析问题的能力及良好的沟通技巧，有良好团队合作精神。

Strong ability to analyze problems and good communication skills, and good team work spirit.

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