工程验证高级合规专员（验证或QA背景）

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

• , 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.