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This role is required to establish Quality Management System strategy from planning to execution at Align China site to fulfill requirements of appropriate domestic and international quality system regulations and standards. is responsible for working seamlessly with site quality head and functional teams to ensure QMS at each site is working in effective way and harmonizing with Align global QMS plan as well.
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Responsible to ensure all applicable quality requirements are achieved and maintained for new product introduction and for transition to new suppliers. The role ensures quality targets are met by acting as a Quality liaison between group and producers, by pro-actively driving, implementing and executing FAI and UPPAP processes.
负责推动符合FDA标准的新建车间的建设,提升与完善质量体系至符合cGMP标准并推动后期的FDA官方审计
-供应商审核:根据不同品类编订和更新审核标准;负责现有供应商的飞行审核和年度审核,并跟进和解决审核发现问题;-供应商管理:督促供应商搭建和完善质量管理体系;主持召开供应商大会,检讨供应商质量绩效达成率并推进持续改善;结合IQC和产线供应商原材料质量表现,进行月度绩效制定和考核,并参加月度绩效会议;
一年内,完成MAH-CMO及MAH-CDMO管理体系建立,并在企业落地实施一年内,结合战略部署,帮助至少2个产品项目技术转移落地。一年内,推进集团内重点项目开展,至少再项目关键节点赋能指导4次其他工作:结合领导安排,协助完成质量板块相关工作。
-负责管理和监督公司的质量管理体系,确保产品质量符合客户要求和行业标准。-制定和执行质量控制计划,协调各个部门之间的合作,以实现质量目标。-解决质量问题,并提出改进措施以提高产品质量和客户满意度。
This role is the core person of the China management team. as the General Manager, he is in charge of the entire P&L and operations in China.
As the manufacturing plant operation manager, he oversees all operational aspects of the plant, ensuring efficiency, quality, and safety standards are met. He reporting directly to the plant's General Manager, he provides regular updates on performance and strategic initiatives. Additionally, he maintains a dotted line relationship with the global function head, aligning local operations with broader corporate objectives and practices.
1. Collaborate with suppliers to establish and maintain rigorous quality standards for raw materials and finished products.2. Develop and implement quality control processes to ensure adherence to company standards and regulatory requirements.
Our client is the Education division of a global renowned press. The business facing International Schools has gained a sound momentum, and we need more people join to develop the business together.
As a key individual contributor part of a R&D team to drive the functional ingredients innovation by cooperating with external partners.
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