锦鲤求职岗位描述
工作职责JOB RESPONSIBILITY
1. 审计与检查管理（Audit Management）
负责领导中国区GMP仓库区域的官方检查、客户审计、内部审计、及其他内外部审计活动，包括但不限于仓库相关审计的准备、现场接待、体系介绍、问题回复及审计总结等工作，确保审计活动顺利开展并达到预期目标。
负责跟踪并推动仓库相关审计发现项的整改落实，组织制定CAPA措施，并对整改有效性进行验证和评估，确保问题得到持续改进和闭环管理。
每年组织对各基地仓库开展GMP内部检查，识别质量和合规风险；负责仓库审计SME的培养、培训及能力考核，确保各基地仓库GMP法规复合型，确保公司基地仓库管理系统标准化，执行有效性。
2. 质量体系与标准化建设（Quality System & Standardization）
负责全球范围内新仓库质量体系的搭建与导入，推动现有仓库质量体系持续优化和标准化管理。
参与仓储运营和物流管理相关精益项目，识别风险与改进机会，推动质量管理体系的持续提升。
3. 海外支持（Overseas Support）
为海外仓库及国际业务提供质量体系、GMP/GDP及仓储管理方面的专业支持，确保全球仓库符合公司标准及法规要求。
支持海外新仓库体系建设、运营启动及质量管理标准落地，推动全球仓库管理模式标准化的建立。
协调海外基地仓库相关GMP审计、检查及客户评估活动，为跨区域项目提供质量与合规支持。
1. Audit Management
Lead regulatory inspections, customer audits, internal audits, and other internal and external audit activities for GMP warehouse operations in China. Responsibilities include audit preparation, on-site hosting, quality system presentation, response to audit observations and inquiries, and audit summary reporting, ensuring audits are conducted smoothly and achieve the intended objectives.
Track and drive the timely completion of corrective actions for warehouse-related audit findings. Organize the development of CAPAs (Corrective and Preventive Actions), verify their effectiveness, and assess implementation outcomes to ensure continuous improvement and effective closure of compliance issues.
Organize annual GMP internal inspections across all warehouse sites to identify quality and compliance risks. Develop, train, and assess Warehouse Audit Subject Matter Experts (SMEs), ensuring strong GMP regulatory expertise across sites and promoting standardized warehouse management systems and effective execution throughout the organization.
2. Quality System & Standardization
Lead the establishment and deployment of quality management systems for new warehouses globally, while driving continuous optimization and standardization of existing warehouse quality systems.
Participate in warehousing and logistics operational excellence initiatives, identifying risks and improvement opportunities to continuously enhance the effectiveness of the quality management system.
3. Overseas Support
Provide professional support to overseas warehouses and international business operations in the areas of quality systems, GMP/GDP compliance, and warehouse management, ensuring alignment with corporate standards and regulatory requirements.
Support the implementation of quality systems, operational start-up activities, and quality management standards for newly established overseas warehouses, driving the development of a standardized global warehouse management model.
Coordinate overseas warehouse audits, inspections, and customer on scene assessments, and provide quality and compliance support for cross-regional projects and initiatives.
教育程度/经验Education background/ Experience
本科及以上学历，10年以上GMP质量管理，GMP仓库管理或生产管理工作。
Bachelor’s degree or above, more than 10 years of experience in the pharmaceutical industry of involvement in GMP quality management, warehouse management, production management.2
其他要求（比如工作时间或特殊技能等）Other requirements (e.g.: working time, special skills)：
熟知GMP仓库管理流程和质量控制要求，熟悉各国GMP法规指南，包括并不限于美国21 CFR Part210/211，EU GMP（Volume4），ICH Q9，Q10，NMPA 药品生产质量管理规范，中国药品GMP指南。
具备法规审计沟通能力，能够清晰，准确回应国外内GMP法规审计，客户审计问询，完整阐述体系，流程与实际执行情况。
掌握专业中英文术语，熟练开展双语审计应答，准备理解审计官提问，梳理证据逻辑，结合SOP，记录凳GMP文件，有理有据解释工艺，质量体系，风险管控等相关问题.
团队管理经验，有效组织带领仓库审计团队完成仓库业务对应工作。
能够接受国内外出差工作安排。
Thorough knowledge of GMP warehouse management processes and quality control requirements, with a strong understanding of global GMP regulations and guidelines, including but not limited to U.S. 21 CFR Parts 210/211, EU GMP (Volume 4), ICH Q9, ICH Q10, NMPA Good Manufacturing Practice (GMP) for Drugs, and the China GMP Guidelines.
Strong communication skills in regulatory and quality audits, with the ability to clearly and accurately respond to GMP regulatory inspections and customer audits both domestically and internationally, effectively explaining the quality system, operational processes, and actual execution practices.
Proficient in professional terminology in both Chinese and English, capable of supporting bilingual audit responses. Able to accurately understand auditors' inquiries, organize supporting evidence and logical justifications, and leverage SOPs, records, and other GMP documentation to provide well-reasoned explanations regarding processes, quality systems, risk management, and compliance-related matters.
Demonstrated team management experience, with the ability to effectively organize and lead warehouse audit teams to successfully execute audit-related activities and ensure compliance with warehouse operations requirements.
Able to travel domestically and internally for business purpose