质量合规高级经理-化药方向

职位描述
岗位职责 Responsibilities:
1. 负责小分子QC部门客户和官方审计工作，重点涵盖后期项目的审计工作，包括审计前准备、审计中问题协调、审计后发现项追踪及反馈；
Responsible for coordinating client audit and regulatory inspection within the small molecule QC (SMQC) department, focus on audit for late stage projects, including pre-audit preparation, problem coordination during audit, tracking and feedback of findings after audit;
2.建立和更新小分子QC审计资源库、优化审计流程，协助提高QC团队应对审计的能力；
Establish and update SMQC audit resource library, optimize the audit process to assist in improving SMQC team 's ability to respond to audits.
3. 药典和法规的协调和监督进展,针对相关更新进行差距分析和相关CAPA跟踪。
Coordinate and monitor the progress of pharmacopoeias and regulations, conduct gap analysis and related CPAP tracking for relevant updates.

任职要求 Job Requirements:
1.本科及以上 具有至少8年从事 GMP制药行业QC或者QA 合规审计经验；
Bachelor degree or above. At least 8 years of experience in pharmaceutical GMP QC or QA compliance or GMP inspection
硕士及以上， 具有至少5年从事GMP制药行业QC 或者QA 合规审计经验；
Mater degree or above. At least 5 years of experience in pharmaceutical GMP QC or QA compliance or GMP inspection
2.了解FDA/EMA/NMPA GMP法规；
Knowledge In FDA/EMA/NMPA GMP regulation
3.熟悉FDA/中国/欧盟法规及ICH等的要求；
Familiar with FDA/China/EU and ICH GMP requirements
4.良好的沟通协作能力
Good communication and coordination skills
5.良好的计算机办公技能和数据分析
Good computer skills and data analysis
6.良好的英文听说读写能力尤佳
Perfect for good English listening, speaking, reading and writing skills.