QC 项目管理 QC Function Lead

As QC point of contact and project management personnel, 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联络人和项目管理人员，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 岗位要求： 教育程度/经验Education background/ Experience Bachelor or MS in Analytical Chemistry, Biochemistry, Microbiology, Biology, Molecular Biology, Biological Engineering, or related fields. Degree of Master, or a Degree of Bachelor with at least 2 years of pharmaceutical industry experience 分析化学、生物化学、微生物学、生物学、分子生物学、生物工程或相关领域学士或硕士。 硕士学位，或具有至少2年医药行业工作经验的学士学位 其他要求（比如工作时间或特殊技能等）Other requirements (e.g.: working time, special skills) Knowledge and expertise in at least one of the following fields: Biochemical assays such as ELISA, cell based assay, qPCR, Western blot, enzyme activity testing; Separation assays such as HPLC, CE, gel electrophoresis; Biophysical assays such as MS, spectroscopy (UV, FTIR, CD, fluorescence, etc.), DSC 拥有以下至少一个领域的知识和专业知识： 生物化学试验，如ELISA、基于细胞的试验、qPCR、蛋白质印迹、酶活性检测；分离试验，如HPLC、CE、凝胶电泳；生物物理试验，如MS、光谱学（UV、FTIR、CD、荧光等）、DSC Outstanding oral and written communication skills in both English and Chinese Critical thinking, scientific reasoning and problem solving skills Good project management, time management, and multitasking skills Strong interpersonal skills with the ability to work effectively with a wide variety of professionals. Good computer operation skill, intermediate level in Microsoft Word, Excel, PowerPoint etc. 优秀的中英文口语及书面沟通能力 批判性思维、科学推理和解决问题的技巧 良好的项目管理、时间管理和多重任务处理的技能 较强的人际交往能力，能够与各种专业人员有效合作。 良好的计算机操作技能，Microsoft Word、Excel、PowerPoint等工作软件使用水平中等以上