QA 体系文件管理员

工作职责：

协助按照文件/记录管理操作规程中的要求执行文件/记录管理工作Assist in the execution of document/records management as required in the document/records management operating procedures

负责受控记录（受控纸/记录本/实验记录本/等）的分发、回收以及扫描归档

Responsible for the distributing, recycling, scanning and archiving of controlled documents (controlled paper/record book/experimental record book etc.).

追踪记录分发回收，并进行定期的审核

Tracking records distribution and recovery, and conduct regular review

协助维护管理文件的电子化系统 Assist in maintaining an electronic system for managing documents

起草修订GMP 体系文件管理相关的操作规程

Draft and revise operating procedures related to document management.

遵守公司的规章制度，遵守保密制度，坚持保密原则 Obey the regulations of company, obey the confidential regulation and insist the confidential principle.

参与公司内外部审计，回复客户和官方审计，并追踪改正措施的执行情况；Participate in internal and external audit and respond to client and/or official audit. Follow up corrective action implementation;

负责提醒工作相关质量回顾数据的汇总，并定期汇报工作情况

Be responsible for reminding the summary of quality management review data related to the work and regularly reporting the work

按时完成领导安排的相关工作； Complete the related work assigned by the leader on time；

任职要求：

· 具备医药或相关专业本科及以上教育背景，且熟悉GMP管理工作

· Have bachelor degree or above education background in medicine or related specialty, and be familiar with GMP management

· 熟悉生物制药质量体系的建立，运营及维护 Familiar with quality system establishment, operation and maintenance

· 熟悉中国， FDA 和欧盟 GMP 法规和指南的要求 Familiar with China, FDA and EU GMP regulations and guidelines

· 中英文听说读写能力良好 Good listening, speaking, reading and writing ability in Chinese and English

· 良好的沟通协调能力 Good communication and coordination skills