• Coordinate related stakeholder according to the site’s project master plan to ensure that the site’s LIMS system is deployed according to Sanofi’s system, ensuring compliance with quality, documentation and GMP and environmental/safety/health requirements
根据工厂的项目主计划,协调各个利益相关方,确保工厂LIMS系统按赛诺菲的体系部署,确保符合质量、文件记录和GMP以及环境/安全/健康的要求。
• Use digital tools to lead the optimization of laboratory processes and methods, improve laboratory regulatory compliance and test efficiency
运用数字化的工具,引领实验室流程和方法的优化,提高实验室的法规符合性和检验效率。
• Assure all test perform according plan, assure all of instrument can support testing work, assure all the analyses are carried out in compliance with analytical methods. Assure quality, Good Documentation Practices, cGMP, safety health and environmental standards are met.
确保检验按计划要求进行,确保仪器设备能支持检验工作按照分析方法进行,确保符合质量、文件记录和GMP以及环境/安全/健康的要求。
• Drafts standard operating procedures, analytical methods and instrumental validation/verification protocols, Assure the validation/verification carried out correctly.
编写标准操作规程和分析检验方法,并确保设备和分析方法的验证和确认正确执行。
• Training and support analyst in LIMS operation field
对检验员在LIMS操作领域的工作给予培训和支持