Summary
About the Role
~ 确保质量体系符合全球准则，并遵守所有相关法规和法律要求，以 GxP 建立质量体系，并监控定期检查和更新质量相关流程
~ 不断改进和协调质量相关流程，强化质量意识、技术服务意识、质量相关产品检测意识，消除与工艺相关的壁垒，并预测质量问题。
~ 在发生质量保证问题时支持部门
~ 通过识别、评估、缓解和沟通任何潜在监管，支持监管风险管理
合规风险
~ 执行自我评估
~ 支持合规性和质量文化
~ 提供专家建议和意见，协调并持续优化 QA 领域的流程
~ 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
•确保遵守和进一步发展、支持、维护和不断审查质量系统，支持项目，并报告必要的绩效指标 （KPIs） 和质量指标 （KQI）。支持实施有效高效的流程，以可持续的方式满足监管要求 ， 满足全球诺华产品组合的期望。
Work Experience
~项目管理
~职能广度
~维系/重振
Skills
~质量管理体系 （Qms）
~Gxp（吉特普）
~行业标准
~决策能力
~合规要求
~质量标准
~项目管理
~风险管理
~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? https://www.novartis.com/about/strategy/people-and-culture
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
