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负责工厂的大分子生物药商业化生产的质量全面管理。
This job is take charge of clinical Quality Management System (cQMS) building up and maintenance to ensure all clinical development activities' quality in line with the company's strategy, ICH-GCP and international regulations.
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.
负责公司药物质量研究工作及质量管理体系的建立和发展。
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。
我们的客户是由一群具有使命感的清华博士联合成立,致力于解决制药行业上游研发设备的技术瓶颈。目前已有三款产品实现商业化,进入规模量产阶段。伴随企业成长亟需了解GMP和FDA的质量专家,来建立质量管理体系,协助企业走向国际化市场。
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
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。
It's a leadership position to oversee global production, supply chain, warehouse and logistics team operations in Asia. You will work in a fast paced environment with expanding plans.
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