Overall Objectives of the Position 职位目标：
61 Conduct audits of manufacturers, laboratories, supplier, etc. to assure compliance to cGMPs/ISO.
对制造商、实验室、供应商等进行审计，以确保符合cGMPs /ISO要求。
61 Provides assistance in maintaining training program.
对培训计划提供协助支持。
61 Resolve quality concerns and implement quality improvements by meeting with other department Managers, Supervisor to assure current methods, procedures or SOP’s meet current standards.
与其他部门经理、主管一起会议解决质量问题并实施质量改进，以确保当前的方法、程序或SOP符合当前的标准。

Main Tasks 主要职责：
61 To work with global Supplier Quality Management team to ensure compliance with global strategy.
与全球供应商质量管理团队合作，确保符合全球战略。
61 To manage all quality audit aspects of Suppliers, Contract Manufacturing Organizations (CMO’s), Repackagers, Distributors, Warehouses, Contract Laboratories as appropriate.
管理供应商、合同制造组织（CMO）、包装商、分销商、仓库、合同实验室的所有质量审计。
61 Responsible for supplier /CMO quality audit, timely provide audit report and supplier CAPA, and follow up supplier CAPA until the final audit.
负责供应商/CMO的质量审计，及时提供审计报告以及供应商的CAPA，并跟踪供应商的CAPA至最终审计结束。
61 To implement and execute activities associated with and relevant to the supplier quality audit tasks and other tasks that may support and enhance the safety and integrity of sourcing from China.
实施和执行与供应商质量审计任务和其他任务相关的活动，以支持和加强从中国采购的安全性和完整性。
61 Perform risk management and routine surveillance of suppliers.
对供应商进行风险管理和日常监督。
61 To manage raw material and packaging material complaints to better support production.
负责原辅料和包材的投诉以更好地支持生产工作。
61 To conduct internal GMP/ISO audits of the manufacturing facilities to ensure GMP/ISO compliance.
对生产设施进行内部GMP/ISO审计，确保符合GMP/ISO要求。
61 To support customer audit and follow up of CAPA’s with internal department and make sure the audit closed in time.
支持客户审计并跟进内部部门的CAPA，确保审计及时关闭。
61 To support quality system related works including deviation, change control, CAPA, risk management and so on.
支持质量体系相关工作，包括偏差，变更，CAPA，风险评估等。
61 Provides assistance in maintaining training program.
对培训体系的维持提供帮助。
61 Strictly comply with company EHS safety regulations and master skill of safety work and emergency rescue knowledge.
严格遵守公司EHS安全法规，掌握安全工作技能和应急救援知识。
61 To support Emprove Documentations as per company strategy.
根据公司的战略支持Emprove文档。
61 Other assigned works from line manager.
其他由直线经理分配的任务。
61 Actively participate in quality culture building and quality related activities.
积极参与工厂的质量文化建设和质量相关活动。
61 Actively report quality related events and participate in continuous quality improvement activities.
主动汇报质量相关事件，积极参与工厂的质量持续改进的活动。

Education and Qualification Required 教育背景及任职要求
61 Education: Bachelor or above.
学历：本科或以上
61 Working Experience:
工作经验：
1. Minimum 10 years of working experience in a pharmaceutical or biological GMP/ISO environment with some auditing experience.
至少10年制药或生物GMP/ISO工作经验，有一定的审计经验。
2. Expert knowledge of domestic and international regulations regarding Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) for Active Pharmaceutical Ingredients (APIs) and pharmaceutical/biological products.
对原料药和制药/生物制品的GMP和GDP相关的国内和国际法规具有专业知识。
3. In-depth knowledge of Quality Systems and related norms (e.g. ICH Q7/8/9/10, ISO 9000 series)
深入了解质量体系和相关规范（如ICH Q7/8/9/10, ISO 9000系列）。
61 Technical & Professional Knowledge:
技术&专业知识：
1. Fluent in English. Good reading, writing and communication skills.
流利的英语，良好的阅读、写作和沟通技能。
2. Skilful in using office application software (MS-Word, MS-Excel, MS-Outlook)
熟练使用office办公软件(MS-Word、MS-Excel、MS-Outlook)。
3. Inter-cultural competence
跨文化能力。
4. Willing and being able to travel at least 30% of the time.
愿意并能够接受至少30%的出差时间。