职位描述
职责 Responsibility:
1. 负责供应商质量管理团队的日常管理
Responsible for the daily management of the Supplier Quality Management team.
2. 带领团队完善和优化各类供应商管理的质量管理体系,确保供应商质量管理符合GMP和相关法规要求;
Lead the team in improving and optimizing quality management systems for supplier management, ensuring compliance with GMP and relevant regulations.
3. 负责供应商的资质评估、供应商资质维护,落实日常管理工作;
Conduct supplier qualification assessments, maintain qualification records, and carry out daily management.
4. 根据物料风险和供应商风险,制定供应商年度审计计划,并对供应商质量体系、质量文件、质量控制执行的符合性进行评估;
Develop annual supplier audit plans based on material and supplier risks, and evaluate the compliance of suppliers' quality systems, documents, and quality control implementation.
5. 负责处理与供应商相关的异常事件的内外部沟通与跟踪,监督供应商质量相关的整改,指导/参与供应商整改的跟踪直至闭环,以及内部解读供应商提供的回复和报告;
Handle internal and external communication and follow-up on supplier-related deviations, oversee the implementation of supplier quality corrective actions, guide/participate in tracking supplier corrective actions until closure, and internally interpret responses and reports provided by suppliers.
6. 负责完成供应商质量绩效的管理,对供应商质量周报/月报/季报/年报进行统计分析,定期组织召开供应商管理分析,持续监控供应商质量管理水平;
Manage supplier quality performance by conducting statistical analysis of supplier quality weekly/monthly/quarterly/annual reports, organize regular supplier management review meetings, and continuously monitor supplier quality management levels.
7.能够独立负责供应商质量审计,包括审计准备、审计组织和执行,以及审计后整改跟踪。
Independently conduct supplier quality audits, including audit preparation, organization, execution, and post-audit corrective action follow-up.
任职要求:
Requirements:
1. 药学相关专业,本科及以上学历;
Educational Background in Pharmacy or related discipline, with a Bachelor's degree or above.
2. 好的GMP药品质量和生产经验,具有6年以上供应商质量管理经验;
Solid experience in GMP pharmaceutical quality and production, with at least 6 years of experience in supplier quality management.
3. 熟悉原辅包相关物料的现场监控及质量体系评审等工具及方法;
Familiar with on-site monitoring and quality system audit tools/methods for materials related to raw materials, excipients, and packaging.
4. 具有独立解决问题的能力,原则性强,具备良好的内外部沟通和协调能力;
Strong problem-solving skills, adherence to principles, and excellent internal and external communication and coordination abilities.
5. 具有良好的数据分析能力,可以从不同维度和角度分析总结数据;
Proficient in data analysis, capable of analyzing and summarizing data from different dimensions and perspectives.
6.良好的英文听说读写能力。
Good English listening, speaking, reading, and writing skills.
以担保或任何理由索取财物,扣押证照,均涉嫌违法,请提高警惕