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Job Description

Amgen China Senior Quality Associate

安进中国高级质量助理

The International & Distribution Quality (IDQ) team supports products to and in the market after our manufacturing sites have produced high-quality medicines for our patients. The China IDQ team is a commercial-facing group that has oversight over finished drug product distribution in China. This oversight includes business partners, Logistics service providers, distributors, wholesalers, contract packaging, import testing laboratories product complaints, and Affiliate QMS to ensure our products are safe and effective.

中国国际与分销质量（IDQ）负责支持产品进入中国市场并在市场上流通。中国IDQ团队是一个面向商业的团队，负责监督在中国的成品药品分销。这项监督工作包括业务合作伙伴、物流服务提供商、分销商、批发商、合同包装、进口测试实验室、产品投诉以及附属质量管理系统（QMS），以确保产品安全有效。

The Senior Quality Associate is responsible for leading and conducting the following Quality Assurance activities to support China GSP/GMP requirements as well as JAPAC regional activities where required.

高级质量助理负责领导和执行以下质量保证活动，以支持中国GSP/GMP要求以及在需要时支持JAPAC区域活动。

Responsibilities include, but not limited to:

职责包括但不限于：

• Support activities to maintain the quality system and execute tasks in compliance with Amgen’s Quality Management System, GDP/GMP requirements and any local applicable regulations.

支持维护质量体系的活动，并按照安进的质量管理体系（QMS）、GDP/GMP要求和任何适用的本地法规执行任务。

• Completes required assigned training to permit the execution of required tasks

完成所需的指定培训，以便执行所需的任务。

• Conduct GSP remote and on-site Due diligence visit and/or Inspection, may extended to GMP related.

进行GSP远程和现场尽职调查访问和/或检查，可能扩展到GMP相关内容。

• Alerts any quality, compliance, supply and safety risks.

警示任何质量、合规、供应和安全风险。

• Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.

确保生产记录和测试结果完整、准确，并按照书面程序和cGMP要求记录。

• Conduct Product complaint outbound work per the guidelines, such as reconciliation of Product complaint samples.

根据指南进行产品投诉外部工作，例如产品投诉样品的协调。

• Provide quality guidance for commercial programs including patient support programs and Product Complaint training

为商业项目提供质量指导，包括患者支持项目和产品投诉培训。

• Consolidation of information on complaint sample returns and replacements. Handling of complaint‑related OBT activities. Tracking and follow‑up of complaint return samples.

整合投诉样品退货和更换信息。处理投诉相关外部任务。跟进投诉退回样品。

• Updating and maintenance of complaint training materials. Continuous optimization of complaint‑related communication and responses in collaboration with cross‑functional teams across Amgen China.

更新和维护投诉培训材料。与安进中国的跨职能团队合作，持续优化与投诉相关的沟通和回复。

• Provide support for supplier onboarding. Submission of payment requests for reagents.

供应商准入支持, 提交试剂付款申请。

• Communicate with Logistics service partners and cross-functional departments for routine tasks, and physical visit to LSP/distributors.

与物流服务合作伙伴和跨职能部门进行日常任务的沟通，并实地访问LSP/分销商。

• Manage documentation and the archive of all the relevant documents.

管理文件和所有相关文件的存档。

• Support Company Secretarial affairs when needed.

在需要时支持公司秘书事务。

• Implement continuous improvement practices and work hard to meet organizational objectives.

实施持续改进实践，并努力实现组织目标。

• Performs review and tracking of cGMP/GDP and QMS processes documents and records. 

执行cGMP/GDP和QMS流程文件和记录的审核和跟踪。

• Experienced in planning, organizing and problem-solving to complete multiple deadline-driven projects efficiently and on time.

具备计划、组织和解决问题的经验，以高效、按时完成多个有截止日期的项目。                                                                                     

• Bachelor’s degree in pharmacy or related majors, Overseas education is preferred.
• Above 3-5 years experience in a pharmaceutical company, preferred to have quality function experience in a distribution company, manufacturing site and/or auditing function.
• 3-5年以上的工作经验，在分销公司、生产现场和/或审计职能方面有质量工作经验的优先考虑。
• Has knowledge of local regulations related to Good Distribution/Supply Practice (GDP/GSP) and Good Manufacturing Practices (GMP).
• /供应管理规范（GDP/GSP）和药品生产管理规范（GMP）相关的本地法规。
• Good written and spoken English and Mandarin.
• Strong project and time management skills, ability to plan tasks and timetable in advance
• Patient, be able to work independently and under pressure.
• Strong initiative, mature, attentive to details and a good team player.
• Problem solving