QC 项目管理
职位描述
Responbibilies
Proactively work with the CMC team of projects and understand the scope of the project and all vital aspects related to QC activities;
Proactively serve as the liaison of QC and communicate with the client and other stakeholders in a project;
Build up timeline for QC team and ensure that all team members understand the scope and deliverable 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 and manage GMP/ regulatory documents;
Ensure that the project is carried out in compliance with cGMP regulations;
Act as a team leader and provide the training, guidance, feedback and review to the QC members as needed;
Support in audits by clients, health authorities, and/or BU internally;
Lead investigation of deviation/OOS/OOT
Qualifications:
Education background in chemistry, biology, or pharmaceutical sciences;
Degree of Master or above is preferable, or a Degree of Bachelor with at least five years of pharmaceutical industry experience;
Outstanding oral and written communication skills in both English and Chinese are essential
Good project management, time management, and multitasking skills are required.
Able to work as a team member and as a leader