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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。
As a key individual contributor part of a R&D team to drive the functional ingredients innovation by cooperating with external partners.
Responsible for establishment and maintenance of FSIn Charge of quality management systemConduct internal and external auditsCommunications and understanding of regulatory authorities
Base on China innovation strategy to develop innovation technical solutions.Work closely with Global team and local ODM/OEM partners to ensure ensure product development process and quality.
Lead Quality Control and Quality Assurance team in plants to manage the respective areas regarding quality systems and various quality requirements of customers. Lead and manage the food safety, food fraud and food defense as required by local regulations.
Collaborate with regional colleagues to manage audit programs for external suppliers in the APAC region.Evaluate and make sure suppliers and quality system fully meet company compliance base on the audit outputs.
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