南京招聘

Position purpose:
To ensure the final product quality, within the limit of relative policy and budget, take charge of supplier management, deal with the internal complaints, follow up CAPA etc., to ensure the materials supply consistently and stably. 为确保公司产品满足质量及相关政策法规要求而采取的有计划的系统性活动，主要包括供应商的管理,内部投能持续稳定得供货。

Major tasks and responsibilities of position:
1.Take charge of local supplier management, including qualification, on site audit, re-qualification of suppliers and prepare annual supplier risk review; 负责本地供应商的管理，包括供应商的确认，审计，供应商再确认及供应商的年度质量风险回顾

2.Lead and investigate the root cause for internal complaints internally and externally, take measures to reduce/avoid similar issues; support the suppliers to improve the quality system to secure product supply; 主导内部及外部调查物料内部投诉的根源, 采取措施减少/避免类似事件再次发生；协助供应商改进质量体系以确保产品供应；

3.Lead local SMRC (Strategic Material Review Committee) meetings, make plan and coordinate activities for developing alternative sources for key products; 牵头本地战略性物料回顾委员会的会议，为我司关键产品开发替代货源制定计划并协调相关活

4.Key local auditor for global auditing team to co-audit the suppliers in China; 作为全球审计团队对中国供应商的审计的主要审计官；

5.Organize GMP self-inspection and follow up the actions for observations to gradually improve the quality management system of BSAH and ensure its consistency with global and local GMP requirement; 组织公司GMP内审，跟进缺陷的改进行动以逐步提高公司的质量管理体系, 确保其符合总部和本地GMP要求

6.Take charge of the management of specifications and test record masters for materials and final products;  负责原料和成品质量标准及检验记录模板的管理；

7.Responsible for assigned annual product reviews; 完成分配的年度产品质量回顾；

8.Train and qualify local auditors；培训并认证当地审计员；

Qualifications :

Education/Experience: Bachelor degree or above, majored in Chemistry, Pharmaceutics or related subjects,at least  5 years of QA experience and herein 3 years of supplier management experience; 教育/经验：化学、药学或相关专业，本科及以上学历，至少5年QA经验，其中3年供应商管理的工作经验

Specific knowledge&skills: Familiar with GMP regulation and quality standard management; Familiar with quality management system; 专业知识：熟悉 GMP规定和质量标准管理知识；熟悉质量管理体系；

Good skills in organization, presentation, analytical and problem-solving; 良好的组织能力、表达能力、分析能力和解决问题的能力；

Good skills in office software using and good English skill in reading/writing/listening/translation; 良好的计算机办公软件应用技能，良好的英语听读写译技能。

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