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独立负责临床试验项目管理。
我们的客户是一家知名上市医药企业，出于业务高速发展的需求，现新增一位集团ITBP经理/高级经理，主要负责集团层面工厂信息化的规划及落地工作
负责CMC团队的建立、完善和管理；制定原料药和制剂的开发策略和生产计划；指导解决新药工艺开发过程中的关键技术问题；负责管理外包研发生产服务供应商；负责与监管部门在CMC方面的沟通和交流；配合临床部门开展临床试验，提供药学方面的支持；配合注册部们完成各项目IND/NDA申报资料的撰写、审查，配合完成现场核查及注册申报。
The Quality Control Manager is accountable for ensuring that assigned co-packers in Asia follow and adhere to Quality Control protocols and produces high quality product. The Quality Control Manager is responsible for performing production site Quality Control audits, in accordance with company Guidelines, site capability assessments and production trials.
An large organisation is looking for a facility management director to ensure all facilities operations and maintenance works and project/construction works are carried out in accordance with the established safety procedures at all times, including systems maintenance safety, site safety, workplace safety and hygiene safety
The R&D Quality Director will be responsible for overseeing all quality-related activities within the R&D department, ensuring compliance with GxP (Good Practice guidelines), supporting innovation, and promoting high standards of product quality and safety. This role is pivotal in establishing a robust Quality Management System (QMS) for R&D and ensuring adherence to Good Manufacturing Practice (GMP) and scientific practices.
1.Provide End to End regulatory expertise to innovation projects in China R&D.2.Ensuring compliance of raw materials and finished cosmetic products developed in line with chemical and cosmetic regulations in China and Asian countries.
