Quality Control Staff Job at Universal Hierarchy Node, 兵庫県 篠山市

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  • Universal Hierarchy Node
  • 兵庫県 篠山市

Job Description

Summary

~高技能和经验丰富的实验室专业人员,通过执行分析释放测试、研究支持、研究支持和稳定性测试做出贡献

About the Role

Major Accountabilities

~ OOx/偏差处理 。
~ CAPA 定义
~ KPI 趋势
~ 确保所有活动符合 cGxP,包括数据完整性审查和批准分析数据/测试(分析发布) 稳定性
~ 稳定性测试(项目)=协议编制、评估、报告准备。
~ 报告(稳定计划编制、趋势分析、评估)
~ 供应商资格稳定性研究、协议和比较报告的性能
~ 审查和批准分析测试(分析版本)
~ 微生物质量控制
~ 对材料和公用设施进行微生物测试,环境和人员监测
~ 为现场认证和验证活动提供专家支持
~ 维护和校准设备,包括计划准备
~ 支持供应商资格
~ KPI/KQI的趋势与分析
~ 支持样品规划和采样执行
~ 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

~高技能和经验丰富的实验室专业人员,通过执行分析释放测试、研究支持、研究支持和稳定性测试做出贡献

Work Experience

~跨界协作
~有3-5年的制药/制造部门GMP环境下的分析实验室工作经验/同等学历
~职能广度

Skills

~实验室设备
~质量控制 (QC) 测试
~质量控制抽样
~全面质量管理
~Gxp(吉特普)
~行业标准
~实验室卓越
~决策能力
~处理歧义
~自我意识
~持续学习
~技术专长

Language

英语

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

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