锦鲤求职岗位描述
1. 计算机化系统验证工作Computerized System Validation Activities
1） 根据验证SOPs和法规的标准决定和建立计算机化系统验证需求，保证系统时刻处于验证和法规符合的状态。 Determine and establish the verification requirements of computerized system according to the standards for verifying SOPs and regulations, to ensure that the system is always in the state of verification and compliance with regulations.
2） 管理计算机化系统的验证工作，使之符合法规、指南等的要求。遵循相应的SOPs，起草计算机化系统生命周期相关的文件，审核供应商及其他部门提供的验证相关文件。 Manage the validation of computerized systems to comply with regulations, guidelines, etc. Follow the corresponding SOPs, draft documents related to the life cycle of computerized systems, and review validation documents provided by suppliers and other departments.
3） 针对计算机系统及其相关附属平台的全生命周期和法规符合性方面，作为关键的责任人和系统所有者和终端用户一起提供质量方面的把控。遵循相应的SOPs，完成或支持在计算机化系统验证中发生的质量事件，如偏离，偏差，变更，CAPA等。 Provide quality control of full life cycle and regulatory compliance of computer systems and other associated ancillary platforms as a key person with system owner and the end-user. Complete or support the quality events follow the corresponding SOPs that occur during the validation of computerized systems such as variations, deviations, changes, CAPA, etc.
2. 客户审计和官方检查 Customer audit and Official audit
1） 现场PAI (预批准检查) 计算机化系统验证方面的协助。 Assisted with site PAI (pre-approval inspection) in CSV prospective.
2） 配合协助完成客户审计工作，回答客户关切的验证问题。Assisted with customer to complete audit work, answer customer's questions about CSV.
3） 配合审计的回复工作，完成发现项的整改。 Assisted with the audit response, complete the rectification of found items.
3. 持续改进Continuous Improvement
1） 负责或支持计算机化系统验证测试项的差距分析及整改。 Lead or support the gap analysis and rectification of computerized system validation test items.
2） 负责相关文件模板改进。 Improve related document templates.
3） 负责流程的优化与分享。 Optimize and share process.
4） 利用公司已有的AI技术和资源，设计并开发智能化平台或应用，推动MEVT部门的验证及相关业务流程的自动化与效率提升，支持部门的数字化转型及持续改进。 Leverage the company’s existing AI technologies and resources to design and develop intelligent platforms or applications that drive automation and efficiency improvements in validation and related business processes for MEVT, supporting the department’s digital transformation and continuous improvement.
4. 其他工作Other Work
完成领导安排的其他工作。
Complete other tasks assigned by the leadership.