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作为生产制造副总全面管理下属生产、质量等多业务板块,提升公司GMP体系符合FDA/EUGMP标准。推动无菌制剂临床样品生产以及后期商业化生产进程。
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.
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
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。
制定和实施品质管理制度和流程,生产品质监控和品质改进、市场品质投诉应对、内部品质培训及团队管理。
The position is a critical position in covering the plant overall operation management. responsibility include but not limit to manufacturing, engineering, lean, quality, EHS etc.
The role will be leading the plant quality department to drive customer quality expectations, accountable to manage the teams of quality control, quality engineering, customer quality, supplier quality engineering, document control, internal audit and training and supervise the incoming quality inspection, quality system management, process quality control and internal/customer audit.
This role involves developing and implementing quality control procedures, conducting inspections, and collaborating with various teams to maintain high standards of quality and customer satisfaction