Quality Assurance Analyst

hace 2 semanas


Insurgentes, México Novartis A tiempo completo

**Summary**:~支持有效的 GxP 合规性和/或审核活动、运营和系统,以确保业务领域符合诺华质量手册和政策以及所有相关的 GxP、法律和法规要求,并通过内部审核、KPI(关键绩效指标)和 KQI(关键质量指标)。~支持外部和公司审计以及卫生局检查的准备和管理。**About the Role**:Major Accountabilities~ 安排和支持PQR/APQR活动~ 支持中心资格认证和验证活动(计划、咨询、审查)~ 实施质量体系(包括文件管理)~ 供应商管理活动(协议、监督、审核)~ 筹备/支助和协调亚太讲习班/后续行动~ 准备和支持审核和检查活动~ 审查/批准变更控制~ 确保本地DI和电子合规性监督(培训,检查,计划,风险ID等)~ 确保流程质量保证符合相关规定~ QP申报审查和批准~ KPI趋势分析~ 确保当地HA的申请、证书维护等~ SPOC,针对HA辖区/国家/地区内所有中心通过HA、GCA/One Voice/整合方法/协作进行沟通~ 收到后 24 小时内报告与诺华产品相关的技术投诉/不良事件/特殊情况~ 营销样本的分发(适用)Key Performance Indicators~支持有效的 GxP 合规性和/或审核活动、运营和系统,以确保业务领域符合诺华质量手册和政策以及所有相关的 GxP、法律和法规要求,并通过内部审核、KPI(关键绩效指标)和 KQI(关键质量指标)。~支持外部和公司审计以及卫生局检查的准备和管理。Work Experience~在制药工业/生物技术领域从事环境监测和清洁区的QC/QA工作**Skills**:~QA(质量保证)~GMP程序~质量标准~技术智能~以行动为导向~功能技能~工艺优化~处理歧义~自我意识~持续学习~技术专长Language英语DivisionOperationsBusiness UnitInnovative MedicinesLocationMexicoSiteINSURGENTESCompany / Legal EntityBR03 (FCRS = BR003) NOVARTIS BIOCIENCIAS S.AFunctional AreaQualityJob TypeFull timeEmployment Type正式Shift WorkNo


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