无锡药明合联生物技术有限公司
QC Digitalization Engineer
岗位职责
负责QC 电子系统与平台建设,实施数智化和自动化解决方案 ,GMP计算机化系统验证工作。Responsible for QC electronic system and platform enablement, digital and intelligent, automation implement, GMP computerize system validation负责QC 相关系统的需求分析、配置、优化和上线支持 Lead
任职要求
analysis, configuration, optimization, and go-live support for QC- related system设计并实施 QC 数智化解决方案,如流程自动化、数据自动采集、报告自动生成、智能看板等 Design and implement digital and intelligent solutions such as workflow automation, automated data capture, report generation, and dashboards按照 GMP / GAMP 5 / 公司质量体系要求,参与或主导 QC 系统的 CSV 活动(URS、RA、DQ、IQ、OQ、PQ 等Participate in or lead CSV activities for QC systems in accordance with GMP, GAMP 5, and company quality systems (URS, RA, DQ, IQ, OQ, PQ)作为 QC 数智化 SME,持续使用创新智能工具支持业务团队在系统和数据层面的能力提升Act as a QC digitalization SME to continuously enhance system and data capabilities within QC teams with innovated tools.
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