QA Specialist (Document Management) QA专员 (文档管理)

 1.    文件管理 Document management

 1.1  负责GMP体系维护与文件管理的工作;Responsible for GMP system maintenance and file management;

 1.2  负责建立文件的起草、复制、分发、收回、销毁及存档的管理流程; Responsible for establishing the management process of drafting, copying, distributing, retrieving, destroying and archiving documents

 1.3  制定文件编号系统,确保每一份文件有专用的编码便于识别、检索; Develop a document numbering system to ensure that each document has a special code for easy identification and retrieval;

 1.4  负责文件体系的电子化管理与维护;文件电子版的更新和维护; Responsible for the electronic management and maintenance of the document system; Update and maintain the electronic version of documents;

 1.5  组织起草、修订、审核、批准相关质量管理文件; Organize the drafting, revision, review and approval of quality management documents;

 1.6  负责有关技术、质量、生产、设备、物流、环境、卫生等文件和记录的归档管理。 Responsible for the archiving and management of documents and records which related to technology, quality, production, equipment, logistics, environment and sanitation.

 2.    档案管理 Archives management

 2.1  负责产品档案、质量档案、技术档案的管理工作,做好档案的整理、保管、借阅、登记等工作; Responsible for the management of product archives, quality archives and technical archives, as well as the arrangement, storage, borrowing and registration of archives;

 2.2  提供相关存档文件资料给予相关部门。 Provide relevant archived documents and materials to relevant departments.

 3.    质量管理 Quality management

 3.1  负责监控公司质量管理体系的执行情况;持续改进和提升质量管理体系; Responsible for monitoring the implementation of the company's quality management system; Continuous to improve and promote the quality management system;

 3.2  参与GMP自检; Participate in GMP self-inspection;

 3.3  协助QA其他功能版块。  Assist QA in other functional sections.


 1.    生物技术、制药或相关专业本科以上学历。 Bachelor degree or above in biotechnology, pharmacy or related field.

 2.    具有制药行业文件管理、质量保证经验者优先。 Experience in document management and quality assurance in pharmaceutical industry is preferred.

 3.    具备起草和审核sop的能力。 Capable of drafting and reviewing SOP.

 4.    良好的计算机操作技能,包括Microsoft Word, Excel, Powerpoint。 Good computer skills, including Microsoft Word, Excel and Powerpoint.

 5.    熟悉GMP和相关法规的要求。  Familiar with the requirements of GMP and relevant regulations.

 6.   关键能力:注重细节、沟通技巧、数据收集与分析、问题分析与解决。 Key skills: attention to details, communication skills, data collection and analysis, problem analysis and solution.