SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES

职位设置目的及主要职责概述

Ensure SSPBP industrial operations and product licenses remain compliant with local regulatory GMP and SP global requirement.

确保公司的生产及产品许可证书符合当地的GMP规定及集团的总体要求

KEY ACCOUNTABILITIES

关键职责

1. To ensure that all manufacturing activities are compliant with approved product license to avoid inspection observations and possible regulatory action;

    确保公司所有的生产活动与批准的产品许可证相一致，避免因为不符而引致的相关药监部门的检查缺陷记录及可能的法规处理措施；

2. To Communicate with Global ICC counterpart for the bulk project;

    为流感新项目与总部的ICC同事沟通

3. To Implement, adapt and roll out Change control process in SSPBP site;

    实施、调整及执行变更控制管理

4. To drive assessment of changes taking into account manufacturing realities, the need for IO flexibility and state of the art interpretation of CMC regulations and guidance;

    对基于生产的实际情况、工厂的适应性需要及当前CMC规章及指引的最新的诠释所做出的变更进行评估

5. To notify and report CMC supplements and variations to global ICC;

    就CMC的补充及变更向总部ICC团队通报及报告

6. To contribute to develop partnership between IO and RA regarding assessment and implementation of industrial changes;

在生产变革的实施及评估上推动工厂及公司注册部门的合作关系

7. To participate global CMC training for well implementation

    参与全球CMC培训，更好地执行相关规定

8. Any other work assigned by SQO responsible related to ICC.

完成本部门负责人委派的其它相关工作

REQUIREMENTS

任职资格

－University qualification or above;

     本科以上学历

－Pharmaceutical and /or biological background, registration rules know-how is necessary;

     药学和/或生物学专业背景，必须具备注册法规的专业知识

－5 years of related experience; Experience in global, multi-function systems, processes and organizations is advantage.

     5年相关工作经验，有全球、多功能体系、流程或机构任职经验者优先

－Computer skill: word, excel at least;

    电脑技能：至少掌握word及excel

－English: Oral, read and writing skill is required, simple communication of French is advantage.

   英语水平：必须掌握说、读、写能力。懂简单法语沟通者优先