协助客户质量体系文件建立项目，与专家一同执行受委托的审计，积累、维护和改善内部文件模板。
岗位描述:协助组织和实施外部客户文件体系建立项目及管理；协助执行质量管理体系的现场审计，包括内审、第二方和第三方审计；协助建立和完善质量管理体系文件模板；参与内部质量管理体系的文件的编写、培训和维护；参与内部质量管理体系要求的其它相关活动。编写GMP相关的技术文件，执行风险评估等 ；项目谈判过程的技术支持。
任职要求:药学、生物科学、制药工程、化学等相关专业；具备药品质量和生产相关专业知识，熟悉海外和中国GMP等法规相关知识；负责质量体系工作5年及以上；良好的中英文听说读写能力。


Assist client to establish projects about the quality system documentation, perform commissioned audits, and accumulate, maintain and improve the internal document templates.
Responsibilities:
1. Assisted in the organization and implementation of external customer documentation system, project establishment and management;
2. Assist the on-site audit of the quality management system, including internal audit, second-party and third-party audit;;
3. Assist in the establishment and improvement of the quality management system document templates;
4. Participate in the preparation, training and maintenance of documents for the internal quality management system;
5. Participate in other related activities required by the internal quality management system;
6. Prepare GMP-related technical documents, perform risk assessments, etc;
7. Technical support for the project negotiation process.
Qualification:
1. Graduated in related fields such as pharmacy, pharmaceutical engineering, chemistry and biotechnology;
2. Professional knowledge of pharmaceutical quality and production, and be familiar with relevant knowledge of overseas and Chinese GMP regulations;
3. More than 5 years experiences in the quality system;
4. Good spoken and written skills in both Chinese and English.