CSV & Process Senior Specialist (Nantong, JS, CN, 226000)
About this opportunity
岗位职责：
负责工厂计算机化系统验证体系的维护；
负责建立工厂计算机化系统验证策略和计算机化系统验证计划，并确保顺利实施；
负责相关的计算机化系统差距分析和补充验证；
负责计算机化系统验证风险评估、验证方案和报告的编制；
负责计算机化系统验证的协调、推进和实施；
协助处理计算机化系统相关的质量事件，包括但不限于偏差、变更、CAPA等；
计算机化系统验证相关法规/指南的培训讲解；
协助分析仪器计算机化系统验证；
完成上级领导交付的其他工作。
任职要求：
本科及以上学历，信息技术或制药相关专业；
制药企业验证工作满6年以上，有计算机化系统验证相关经验；
制药行业验证相关工作6年以上；
良好的英文听说读写能力。
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