工作职责:
1.负责车间现场管理和生产操作的GMP合规性；
Responsible for the GMP compliance of workshop site management and production operation;
2.审核和提高生产记录的合规性；
Responsible for reviewing and improving the compliance of batch production records;
3.负责临床生产部门的文件管理和培训管理工作；
Responsible for document management and training management;
4.负责对临床生产部门发生的偏差、变更、CAPA进行指导；
Responsible for the guidance of deviation, change and CAPA in CM;
5.根据公司临床及研发项目需求，制定临床生产计划并及时更新；
Responsible for making and updating clinical production plan timely, according to the company’s clinical and PD project requirements;
6.负责内外部审计的对接和整改；
Responsible for internal and external audit logistics and rectifications;
7.负责注册申报资料的内部汇总和审核；
Responsible for summary and review of the registration documents;
8.完成上级交办的其他工作。
Complete other tasks assigned by superior.

任职资格:
1、生物、药学或其他相关专业本科学历或以上，在生物技术或生物制药行业至少五年的GMP生产或质量管理经验；Bachelor degree or above in biology, pharmacy or other related field, at least 5 years GMP production or quality management experience in biotechnology or biopharmaceutical industry;
2.熟悉国内外GMP法规，熟悉NMPA、FDA、EMA和ICH生物制品生产有关的指南；Familiar with GMP regulations, such as NMPA, FDA, EMA and ICH of biologics production guiｄｅｌines;
3.有良好的人际沟通能力和组织能力，具备团队协作精神及工作责任感；
With good communication and organizational ability, team cooperation spirit and strong sense of responsibility;
4.有较强的书面和口头表达能力，英语熟练者优先；With excellent written and oral communication skills, English proficiency is preferred;
5.具有在承受较大工作压力的情况下完成多项任务的能力。Complete multiple tasks under high working pressure.
6、熟练的英语读写说能力，熟悉专业术语
Proficient in English and familiar with the professional.

专业要求：不限