锦鲤求职岗位描述
岗位描述 / Job Description
负责公司验证体系的整体建设、管理与持续优化，涵盖设备、设施、公用系统及工艺验证，确保符合GMP及全球法规要求，支撑生产稳定运行及产品质量合规。
Responsible for overall establishment, management, and continuous improvement of the validation system, covering equipment, facilities, utilities, and process validation, ensuring compliance with GMP and global regulatory requirements to support stable production and product quality.
岗位职责 / Job Responsibilities
1. 验证体系建设与管理
负责建立并持续优化公司验证体系，确保符合GMP、FDA、EMA、NMPA等法规要求。
Establish and continuously optimize the validation system to ensure compliance with GMP and regulatory requirements (FDA, EMA, NMPA).
制定验证策略、标准及程序，包括验证主计划及相关SOP。
Develop validation strategies, master plans, and related procedures, including SOPs.
2. 设备及设施验证管理
负责设备、公用设施及厂房验证活动，包括IQ、OQ、PQ的计划与执行。
Lead equipment, utilities, and facility validation activities, including planning and execution of IQ, OQ, and PQ.
确保验证文件的完整性及合规性，并维护验证状态。
Ensure integrity and compliance of validation documentation and maintain validated status.
3. 工艺及清洁验证管理
负责工艺验证、清洁验证及相关验证策略制定与执行。
Lead process validation and cleaning validation activities, including strategy development and execution.
持续优化验证方案，支持产品工艺稳定性与一致性。
Optimize validation approaches to support process stability and product consistency.
4. 再验证与持续验证管理
建立再验证及持续验证机制，确保系统长期保持受控状态。
Establish requalification and continued process verification programs to maintain systems in a validated state.
监控验证状态，评估变更对验证的影响。
Monitor validation status and assess impact of changes on validation.
5. 工程及项目验证支持
支持工程建设项目及设备改造项目中的验证活动，包括C&Q策略制定及执行。
Support validation activities in engineering construction and retrofit projects, including development and execution of commissioning and qualification strategies.
参与设计评审及项目交付，确保满足验证及合规要求。
Participate in design reviews and project delivery to ensure validation compliance.
6. 质量及合规管理
确保验证活动符合GMP及质量管理体系要求。
Ensure validation activities comply with GMP and quality management systems.
支持监管及客户审计，负责验证相关偏差、CAPA及风险评估管理。
Support regulatory and client audits, managing validation-related deviations, CAPA, and risk assessments.
7. 数据与生命周期管理
建立验证数据管理及分析机制，支持生命周期管理。
Establish data management and analysis systems for validation lifecycle management.
推动验证数字化及数据完整性管理。
Drive validation digitalization and data integrity compliance.
8. 团队管理与跨部门协作
建立并管理验证团队，提升团队专业能力。
Build and manage the validation team to enhance technical capability.
与工程、生产、QA及自动化团队紧密协作，推动项目与运维一致性。
Collaborate closely with Engineering, Production, QA, and Automation teams to ensure alignment in projects and operations.
任职要求 / Job Requirements
教育背景 / Education
本科及以上学历，制药工程、生物工程、化学工程或相关专业。
Bachelor’s degree or above in Pharmaceutical Engineering, Bioengineering, Chemical Engineering, or related fields.
工作经验 / Experience
具备8年以上验证相关经验，其中至少3年以上团队管理经验。
Minimum 8 years of validation experience, with at least 3 years in a leadership role.
具备设备、工艺及系统验证的全面经验。
Comprehensive experience in equipment, process, and system validation.
具备工程项目验证经验，参与过新建或改造项目。
Experience supporting validation in engineering construction or retrofit projects.
专业能力 / Technical Competence
熟悉验证全流程及方法（如VMP、IQ/OQ/PQ、CPV等）。
Familiar with full validation lifecycle and methodologies (e.g., VMP, IQ/OQ/PQ, CPV).
具备验证策略制定及技术评审能力。
Strong capability in validation strategy development and technical review.
熟悉GMP法规及国际审计要求。
Solid understanding of GMP and international regulatory expectations.
综合能力 / Leadership & Soft Skills
具备良好的领导力及跨部门协作能力。
Strong leadership and cross-functional collaboration skills.
具备系统性思维及风险管理能力。
Strong systemic thinking and risk management capability.