工作描述JOB DESCRIPTION

1.1 遵守公司规章制度；

Obey the company regulations;

1.2 负责相应部门偏差、变更、CAPA的审核；

Be responsible for reviewing deviation, change control, CAPA in related department.

1.3 负责偏差、变更、CAPA程序的完善；

Be responsible for optimizing deviation, change control, CAPA procedure;

1.4 负责相应部门偏差、变更、CAPA完成情况的跟踪；

Be responsible for tracking the implementation of deviation, change control, CAPA procedure ;

1.5 负责偏差、变更、CAPA相关记录的保存与归档；

Be responsible for archive of deviation, change control, CAPA related records

1.6 定期向直接上级汇报工作；

Report to supervisor of the job periodically;

1.7 完成上级领导交办的其他工作.

Finish the other jobs assigned by supervisor.

人员资质 PERSONAL QUALIFICATION

1.1 本科及以上学历， 生物学、药学、化学或其它相关专业；

Bachelor degree or above, major in biology, pharmacy, chemistry, or other related major;

1.2 熟悉GMP/cGMP/欧盟GMP等法规；

familiar with the GMP/cGMP/EU GMP regulations;

1.3 3年级以上QA现场工作经验；

With 3 years or above experience of QA online ;

1.4 熟悉统计软件的使用；

Familiar with the usage of statistical software;

1.5 英语读写能力良好。

With good English reading and writing ability.

1.6 有较强的分析问题能力及良好的沟通技巧、工作认真、细致，具有良好的团队合作精神。

Excellent communication, problem-solving, and organization skills, attentive, careful and meticulous, with strong team-work ability.

上班地址：外高桥保税区