QA Administrator 质量管理专员

岗位职责
1、偏差管理：根据流程创建和维护偏差记录，跟进调查、风险评估及CAPA实施进度，整理关闭资料；按要求整理季度偏差总结以及年度偏差趋势分析报告；
Deviation management: Create and maintain deviation records in accordance with procedures; follow up on investigations, risk assessments, and CAPA implementation; compile closure documentation; and prepare quarterly deviation summaries and annual deviation trend analysis reports as required;
2、文件起草/修订：起草年度验证总结报告、验证计划、内审计划、药品质量评审；收集并汇总修订意见，核对文件格式、版本、上传系统并跟进审批、生效；
Document drafting/revision: Draft annual validation summary reports, validation plans, self-inspection plans, and product quality reviews; collect and consolidate revision comments; verify document format and version; upload documents to the system; and follow up on approval and effective status;
3、GSP记录核对与管理：每月初从SAP系统中导出到货验收记录、退货验收记录、在库养护记录，并跟进第三方仓储库房的核对，确保数据真实、完整、可追溯；
GSP record verification and management: At the beginning of each month, export goods receipt inspection, returned goods inspection, and maintenance records from SAP, and coordinate verification with the third-party warehouse to ensure that the data are accurate, complete, and traceable;
4、 进口产品COC/COA翻译核对：就第三方仓储库房或下游发现的翻译错误问题与翻译公司沟通，并跟进处理进度，并对此类问题进行统计；另外，每月抽查一定量的COC/COA，确保翻译准确；
Verification of COC/COA translations for imported products: Communicate with the translation vendor regarding translation errors identified by the third-party warehouse or downstream parties, follow up on resolution progress, and track such issues. In addition, conduct monthly spot checks of a defined number of COCs/COAs to ensure translation accuracy;
5、产品变更通知及质量档案维护：将已批准的产品变更信息通知至生产厂及第三方仓储库房，并同步更新和维护产品质量档案，确保产品信息准确、完整、及时，并与批准的变更信息保持一致；
Product change notification and quality file maintenance: Communicate approved product change information to manufacturing sites and the third-party warehouse, and update and maintain product quality files to ensure that product information is accurate, complete, timely, and consistent with approved changes;
6、供应商/经销商管理：供应商资质维护、定期KPI回顾及会议纪要整理存档、按时完成年度回顾；支持经销商日常管理，包括文件复核、存档等；
Supplier management: Maintain supplier qualification documentation, conduct periodic KPI reviews, prepare and archive meeting minutes, and complete annual reviews on time. Support routine distributor management, including document review and archiving;
7、文件归档：将已批准文件上传至Condor系统；
Document archiving: Upload approved documents to the Condor system;
8、协助GSP培训管理，包括根据年度培训计划组织GSP的培训工作、日常培训KPI追踪、年度培训总结等；
Support GSP training management, including organizing GSP training in accordance with the annual training plan, tracking routine training KPIs, and preparing the annual training summary;
9、协助内审及药监部门的外审，包括资料准备、CAPA跟踪等；
Support self-inspection and external inspections by health authorities, including document preparation and CAPA follow-up;
10、协助药品经营许可证变更及换发相关资料的收集、整理和进度跟踪；
Support the collection and organization of documentation and progress tracking for Pharmaceutical Trade License changes and renewal;
11、完成其他与质量运营支持相关的工作。
Perform other tasks related to quality operations support.

岗位要求
1、本科及以上学历，药学或者医学、生物、化学等相关专业优先；
Bachelor’s degree or above; a major in pharmacy, medicine, biology, chemistry, or a related discipline is preferred;
2、工作认真细致，具备良好的沟通协调能力、执行力和时间管理能力；
Detail-oriented and conscientious, with strong communication, coordination, execution, and time management skills;
3、具备良好的英语读写能力，能够阅读并处理英文邮件和质量文件；
Good written English skills, with the ability to read and handle English emails and quality documents;
4、具有两年以上制药行业相关工作经验者优先；
More than two years of relevant experience in the pharmaceutical industry is preferred;
5、具备GMP、GSP或质量管理相关知识者优先。
Knowledge of GMP, GSP, or quality management is preferred.