Amgen
pharmaceutical
SrAssociateQA
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optimal for Mid candidates.
“Sr Associate QA at Amgen. Skills: Quality Assurance, GDP/GSP, GMP. Support activities to maintain the quality system. Execute tasks in compliance with QMS”
What You'll Achieve.
ensure our products are safe and effective; meet organizational objectives
Industry & Context.
problem-solving; planning; organizing; problem-solving to complete multiple deadline-driven projects efficiently and on time
remote and on-site Due diligence visit, physical visit to LSP/distributors
What They're Looking For.
Must Have
Bachelor’s degree in pharmacy or related majors, 3-5 years experience in a pharmaceutical company, knowledge of local regulations related to Good Distribution/Supply Practice (GDP/GSP) and Good Manufacturing Practices (GMP), Good written and spoken English and Mandarin, project and time management skills, ability to plan tasks and timetable in advance, Patient, be able to work independently and under pressure, initiative, mature, attentive to details, a good team player, Problem solving
Nice to Have
Overseas education is preferred, quality function experience in a distribution company, manufacturing site and/or auditing function
What You'll Do.
Support activities to maintain the quality system
Execute tasks in compliance with QMS
Complete required assigned training
Conduct GSP remote and on-site Due diligence visit
supply and safety risks
Ensure production records and testing results are complete
Conduct Product complaint outbound work
Provide quality guidance for commercial programs
Consolidation of information on complaint sample returns
Handling of complaint-related OBT activities
Tracking and follow-up of complaint return samples
Updating and maintenance of complaint training materials
Continuous optimization of complaint-related communication
Provide support for supplier onboarding
Submission of payment requests for reagents
Communicate with Logistics service partners
Physical visit to LSP/distributors
Manage documentation and archive
Support Company Secretarial affairs
Implement continuous improvement practices
Work hard to meet organizational objectives
Perform review and tracking of cGMP/GDP and QMS processes documents
How You'll Work.
Team & Collaboration
cross-functional coordination; Communicate with Logistics service partners and cross-functional departments; collaboration with cross-functional teams
Communication Scope
Good written and spoken English and Mandarin; communication and responses
Process & Methodology
planning, organizing, problem-solving, complete multiple deadline-driven projects efficiently and on time, project and time management skills, ability to plan tasks and timetable in advance
Full Job Description
## **Career Category** Quality ## ## **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
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