QA 体系培训专员

工作职责：

负责年度培训计划制定、并组织实施 Responsible for annual training plan development and organization implementation.

负责年度培训情况汇总和效果评估 Responsible for annual training summary and effectiveness evaluation.

负责组织各部门建立各岗位的上岗培训内容 Responsible for organizing departments to establish posts and training content.

负责组织员工培训档案建立和维护 Responsible for organizing staff training files， establishing and maintaining

负责监督检查各部门培训执行 To supervise and inspect the training and implementation of various departments.

负责 QA 部门的培训协调相关工作，协调 TCC 维护及优化 SHFX GMP 培训课程； Responsible for training coordination of QA, Coordinate TCC Maintenance and Optimization SHFX GMP Training Course.

负责各部门组织架构、培训记录维护 Responsible for organizational chart, training record maintenance.

负责起草、修订培训管理相关的文件和记录，确保符合 GMP Responsible for drafting and revising training management related documents and records to ensure compliance with GMP.

维护培训体系的电子化系统 Be responsible for maintaining the electronic system of training.

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

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