在责任范围内管理质量方面和项目。
确保和支持全面的 GxP 符合性和符合诺华质量管理系统
About The Role
Major Accountabilities
~ 根据 Novartis 的 SOP 确保变更请求从接收到实施和关闭都能得到管理。
~ 对所有部门进行 GxP 监控,对不合规项进行 QA 调查,跟进纠正措施。 归档相关文件。
~ 协调质量体系和程序的实施,以实施 Novartis 质量手册和质量协议。
~ 确保在国内处理和销售药品的所有方面都符合 Novartis 质量手册和政策的要求,并满足所有相关的 cGMP 法规和立法要求。
~ 确保所有与 cGMP/GDP 相关的活动都有当地的"质量体系"和"标准操作程序",并通过培训和内部审计保持 cGMP/GDP 法规合规性。
~ 保有对当地和国际法规及立法要求和趋势的最新知识,以确保向国家/地区提供所有质量相关事宜的技术支持。
~ 与"供应链管理"(SCM)、DRA 和医疗部门建立良好的工作关系。
~ 确保与监管机构、本地合作伙伴(供应商、第三方、授权商和分销商)和"全球质量保证"保持协调的联系。
~ 确保所有进口药品在投放市场前都要按照现行的程序、注册的规范和当地/国际法规进行检验。
~ 确保有一个有效的"变更控制"流程。
~ 根据"Novartis 质量手册"和当地书面程序管理投诉、召回、仿冒品和产品篡改。 根据需要支持/参与 NEM 案例。
~ 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
在责任范围内管理质量方面和项目。
确保和支持全面的 GxP 符合性和符合诺华质量管理系统
Work Experience
~运营管理和执行
~参与志愿者/社区项目
~职能广度
~跨界协作
Skills
~QA(质量保证)
~质量管理
~调节
~指引
~卡帕知识
~良好的文档实践
~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?
Benefits and Rewards:
Learn about all the ways we'll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
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