QC 项目管理FL (MJ008045)

Gather and convey project information to the QC team and ensure that all team members understand the scope and deliverables of the project. Monitor and analyze QC delivery metrics and other KPIs to assess the effectiveness of QC processes and identify areas for improvement create innovative solutions, and make decisions to facilitate project success. Escalate critical issues to senior management when necessary.

- Client Communication Responsibilities:

Serve as the primary point of contact for clients regarding QC-related matters, maintaining open and transparent communication channels. Understand and address client concerns, expectations, and requirements, ensuring that our QC processes and deliverables meet or exceed their standards. Present QC findings, reports, and recommendations to clients in a clear and concise manner, facilitating effective decision-making. Build and maintain strong client relationships, acting as a trusted advisor and ensuring client satisfaction.

- Internal Coordination Responsibilities:

Work with the CMC team of projects to fully understand the scope of the project and all vital aspects related to QC activities.

Build effective partnership with other internal teams to move projects through all phases of the development and commercial stages.

- Documents draft Responsibilities:

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 requirement, study reports, etc.

- Completing other interim work assigned by leadership.

Requirements:

- Education background in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or other related field

- Degree of Master, or a Degree of Bachelor with at least two years of pharmaceutical industry experience

- 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

- Good computer operation skill, intermediate level in Microsoft Word, Excel, PowerPoint etc.