工作职责
1.负责维护公司质量体系的运行，包括但不限于：
Responsible for maintaining company quality system
operation, include but not limit to:

02
变更/CAPA/质量风险管理/产品召回/管理回顾的维护和改进/ GMP人员的培训管理/文件管理
CC/CAPA/Quality Risk Management/Product
Recall/ Quality management review Maintenance and Improvement/ Management Training
program for GMP staff/Document Management

02
CC/CAPA季度回顾趋势总结及报告
CC/CAPA Quarterly review trend summary and
report

02
质量风险管理计划的制定、执行和跟进
Establish, Implementation and Follow-up of
Quality Risk Management Plan

02
产品召回活动的组织和协调
Organization and coordination of product
recall activities

02
管理层回顾会议的组织和协调，措施跟进
Organization and coordination of Quality
management review meetings, follow-up of relevant actions

02
支持 cGMP 及相关法规/指南差距分析
Support cGMP and relevant Regulations/Guidelines
gap analysis

2.负责支持基地内外部审计工作。
Responsible for site internal and external audit supporting.

3.承办领导交给的其他任务。
Deal with
other tasks assigned by manager.
任职要求
医药相关专业，本科学历及以上
熟悉FDA/中国/欧盟法规及ICH等的要求
熟悉无菌药品生产，熟悉质量体系
熟悉ADC生产尤佳
良好的沟通协作能力
良好的计算机办公技能
良好的英文听说读写能力尤佳