锦鲤求职岗位描述
工作地点：上海或苏州
Location: Shanghai or Suzhou
岗位定位
Position Summary
负责工程及验证体系质量治理与合规管理，支持设施、公用工程、设备、维护及验证活动全生命周期质量监督，推动质量体系建设、审计检查准备、数字化质量管理及持续改进，确保符合GMP法规及公司质量体系要求。
Responsible for Engineering & Validation Quality Governance and Compliance Management across engineering and validation activities, ensuring compliance with GMP regulations and company quality standards through quality systems, inspection readiness, digitalization and continuous improvement.
岗位职责
Responsibilities
审计检查与法规管理
Audit & Regulatory Compliance
支持客户审计、官方检查及整改跟踪。
Coordinate audit, inspection and remediation activities.
开展法规差距分析并推动整改落实。
Conduct regulatory gap assessments and drive compliance improvements.
跟踪法规动态及行业最佳实践。
Monitor regulatory trends and industry best practices.
工程质量与验证治理
Engineering Quality & Validation Governance
为设施、公用工程、设备、维护及验证活动提供质量监督与合规支持。
Provide quality oversight and compliance support for engineering and validation activities.
参与确认、验证、CSV、变更、偏差、CAPA及风险管理活动。
Support qualification, validation, CSV, change control, deviations, CAPA and risk management.
推动质量体系、验证治理及质量文件持续优化。
Drive continuous improvement of quality systems, validation governance and documentation.
跨基地治理与持续改进
Cross-Site Governance & Continuous Improvement
推动各基地工程及验证标准与流程统一。
Harmonize engineering and validation standards across sites.
组织经验分享和持续改进活动。
Facilitate best practice sharing and continuous improvement initiatives.
跟踪关键质量指标及改进项目。
Monitor key quality metrics and improvement programs.
数字化质量管理
Digital Quality Management
建立质量指标监控及趋势分析机制。
Establish quality metrics and trending programs.
利用Power BI等工具开展数据分析和风险识别。
Leverage digital tools for data analysis and risk management.
推动数字化平台、自动化报告及AI应用。
Drive digital platforms, automated reporting and AI-enabled quality initiatives.
卓越运营与能力建设
Operational Excellence & Capability Development
推动Lean、Six Sigma等持续改进工具应用。
Apply Lean and Six Sigma methodologies.
组织法规、质量及合规培训。
Organize quality and compliance training programs.
推动质量文化建设和组织能力提升。
Promote quality culture and capability development.
海外基地支持
Global Site Support
支持海外基地质量体系建设、合规评估及持续改进。
Support quality systems, compliance assessments and improvement initiatives at global sites.
支持审计检查、全球标准统一及数字化转型项目。
Support audits, global harmonization and digital transformation initiatives.
任职要求
Qualifications
教育背景
Education
本科及以上学历，硕士优先。
Bachelor’s degree or above; Master’s degree preferred.
制药、生物、工程、自动化或相关专业。
Major in Pharmaceutical, Biotechnology, Engineering, Automation or related disciplines.
工作经验
Experience
5年以上GMP制药行业质量、验证、工程合规或审计经验。
Minimum 5 years of GMP pharmaceutical industry experience in Quality, Validation, Engineering Compliance or Audits.
具有工程QA、验证QA或验证治理经验优先。
Engineering QA, Validation QA or Validation Governance experience preferred.
具有跨基地或全球项目经验优先。
Multi-site or global project experience preferred.
专业能力
Technical Competencies
熟悉FDA、EMA、NMPA GMP法规及ICH指南。
Strong knowledge of GMP regulations and ICH guidelines.
熟悉设施、公用工程、设备及验证生命周期管理。
Strong understanding of engineering and validation lifecycle management.
熟悉确认与验证、CSV、偏差、变更、CAPA及QRM。
Familiar with qualification, validation, CSV, deviations, change control, CAPA and QRM.
具备数字化质量管理、数据分析或Power BI经验者优先。
Experience in digital quality management, data analytics or Power BI is preferred.
综合能力
Competencies
具备质量治理与合规管理思维。
Strong quality governance and compliance mindset.
具备数据分析、风险管理及问题解决能力。
Strong analytical and problem-solving skills.
具备跨部门、跨基地协作及项目推动能力。
Strong cross-functional and cross-site collaboration capability.
具备良好的英语沟通能力。
Strong English communication skills.