Overview
Quality System Specialist(J10737) Jobs in Shanghai, Shanghai, China at BioRay Pharmaceutical
Title: Quality System Specialist(J10737)
Company: BioRay Pharmaceutical
Location: Shanghai, Shanghai, China
该职位来源于猎聘 职责描述：
- Group Quality System Development (35%) 1. 集团质量体系开发（35%）
- Support the development, maintenance, and continuous improvement of the Group QMS (Quality Management System) – 支持集团QMS（质量管理体系）的开发、维护和持续改进
- Monitor regulatory updates (GMP, ISO 13485, NMPA) and translate them into internal standards – 监测法规更新（GMP、ISO 13485、NMPA）并将其转化为内部标准
- Assist in the planning and follow-up of Group annual quality internal audits and management reviews – 协助集团年度质量内部审核和管理评审的规划与跟进
- Support the harmonization of quality systems across multiple sites/business units – 支持跨多个站点/业务部门的质量体系协调
- Group Document & Records Management (30%) 2. 集团文件与记录管理（30%）
- Manage Group quality documents (QM/SOP/records): drafting, review, distribution, archiving, and version control – 管理集团质量文件（QM/SOP/记录）：起草、审核、分发、存档和版本控制
- Collect, consolidate, and trend Group quality records – 收集、整理和分析集团质量记录的趋势
- Operate and maintain the Document Management System (DMS) and access controls – 操作和维护文件管理系统（DMS）及访问控制
- Investigate document/record deviations and follow up on CAPAs – 调查文件/记录偏差并跟进纠正和预防措施（CAPA）
- Group Quality Training (15%) 3. 小组质量培训（15%）
- Develop and execute the annual Group quality training plan – 制定并执行集团年度质量培训计划
- Organize Group-level quality training programs (GMP basics / regulatory updates / specialized topics) – 组织集团层面的质量培训项目（GMP基础/法规更新/专业主题）
- Evaluate training effectiveness and drive continuous improvement – 评估培训效果并推动持续改进
- Manage training records and archives – 管理培训记录和档案
- Key Project Coordination (15%) 4. 重点项目协调（15%）
- Coordinate and follow up on key Quality Department projects (Quality Month, special improvement initiatives, audit readiness, etc.) – 协调并跟进质量部的关键项目（质量月、专项改进举措、审计准备等）
- Act as a communication bridge between Group HQ and sites/business units – 作为集团HQ与各站点/业务单元之间的沟通桥梁
- Organize cross-functional meetings, prepare minutes, and track action items – 组织跨部门会议、准备会议纪要并跟踪行动事项
- Provide project status updates and risk alerts – 提供项目状态更新和风险预警
- Other Support (5%) 5. 其他支持（5%）
- Collect, analyze, and trend quality KPIs – 收集、分析和跟踪质量关键绩效指标
- Support regulatory and external audits – 支持监管和外部审计
- Other tasks assigned by leadership – 领导交办的其他任务 任职要求： Qualifications 任职资格 Education & Experience 教育背景与工作经历
- Education: Bachelor's degree or above in Pharmacy, Biology, Chemistry, Chemical Engineering, or related field – 教育背景：药学、生物学、化学、化学工程或相关领域的学士学位或以上
- Experience: 2+ years in pharmaceutical industry – 工作经验：2年以上制药行业经验 Language & Soft Skills 语言与软技能
- Communication & Coordination: across departments and levels – 沟通与协调：跨部门和层级
- Learning Agility: responsive to fast-changing regulations – 学习敏捷性：对快速变化的法规做出响应 Preferred Qualifications 优先资格
- CET-6 or above; conversational English (phone conferences / foreign visitor reception); able to read English professional literature, including but not limited to PubMed academic papers, ICH/FDA/EMA guidelines, USP/EP pharmacopoeia, etc. – 大学英语六级及以上；英语口语（电话会议/外宾接待）； 能够阅读英文专业文献，包括但不限于PubMed学术论文、ICH/FDA/EMA指南、USP/EP药典等。
