QA Specialist (Product Management) QA专员(产品管理)

 1.    产品管理 Product management

 1.1  负责血样放行;Responsible for blood sample release;

 1.2  负责产品发运的现场监督;Responsible for on-site supervision of product delivery;

 1.3  负责批次生产的现场监督、记录审核、清场确认等关键环节确认;Responsible for on-site supervision, record review, clearance confirmation and other key links of batch production;

 1.4  巡视生产现场,监督生产现场的所有活动符合GMP;Inspect the production site, and supervise that all activities on the production site conform to GMP;

 1.5  负责产品各类标签、空白批记录(批生产记录和批检验记录)的打印、发放;Responsible for printing and issuing labels and blank batch records (batch production records and batch inspection records);

 1.6  负责产品放行前对批生产记录进行审核、汇总;Responsible for reviewing and summarizing batch production records before product release;

 1.7  负责产品放行后对批档案的整理、归档。Responsible for organizing and archiving batch files after product release.

 2.    GMP体系合规管理 GMP System compliance management

 2.1  建立相关的质量保证体系文件; Establish quality assurance system documents;

 2.2  审核体系内各个部门的管理、操作等文件;Review the management and operation documents of each department in the system;

 2.3  参与产品相关的质量风险管理,如风险识别、风险评估、风险控制等;Participate in product-related quality risk management, such as risk identification, risk assessment, risk control, etc.;

 2.4  维护QMS质量管理体系,负责产品涉及的偏差管理、变更控制、CAPA等的处理与跟踪,协助根本原因分析;Maintain QMS quality management system, be responsible for dealing and tracking of the deviation management, change control, CAPA and ect., and assist in root cause analysis;

 2.5  负责监控公司质量管理体系的执行情况,持续改进公司质量管理体系。Responsible for monitoring the implementation of the company's quality management system and continuously improving the company's quality management system.

 3.    其他QA职能: Other QA functions:

 3.1  协助QA其他功能版块; Assist QA in other functional areas;

 3.2  参与GMP自检。 Participate in GMP self-inspection .


 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.    具有制药行业质量保证、质量审计经验者优先。 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.