QC Function Lead

As QC representatives, to participate in projects from early product development stage to final commercial production. Work with the CMC team of projects and understand the scope of the project and all vital aspects related to QC activities Build effective partnership with other internal teams to move project through all phases of the development and commercial stages. Serve as the liaison of QC and communicate with the client and other stakeholders in a project. Build and maintain excellent relationships with clients. Gather and convey project information to the QC team and ensure that all team members understand the scope and deliverables of the project Prepare and track the schedule of QC activities and ensure that the QC part of the project is carried out on time Prepare GMP documents, including but not limited to release and stability protocols, in-process sampling and testing protocols, special study protocol per client’s

, study reports, etc. Complete other tasks assigned by supervisor Ensure that the project is carried out in compliance with regulations 作为QC代表参与从早期产品开发到最终商业生产的项目。与CMC项目团队合作，了解项目范围以及与QC活动相关的所有重要方面 与其他内部团队建立有效的伙伴关系，以推动项目从进入开发到商业生产的所有阶段的有效实施。 作为QC的联络人，与项目的客户以及其他利益相关者沟通。与客户建立并保持良好的关系。 收集并向QC团队传达项目信息，并确保所有团队成员了解项目的范围和可交付成果 制定并跟踪QC活动时间表，确保项目的QC部分按时进行 准备GMP文件，包括但不限于放行和稳定性方案、过程取样和检测方案、根据客户要求的特殊研究方案、研究报告等。 完成主管分配的其他任务 确保项目的实施符合法规要求