项目QA经理

该职位来源于猎聘 Job Responsibilities:

• Participate in internal and external project meetings, and coordinate QA-related activities both internally and externally for the project.
• Review and track project deviations, change controls, and OOX to ensure timely and appropriate closure.
• Review project transfer-related documents, including validation protocols, reports, SOPs, blank batch manufacturing records, process validation documents, and sampling plans for analytical methods involved in the project.
• Review and follow up on the execution of quality agreements.
• Complete the delivery of project documentation as required.
• Establish, optimize, and maintain operational procedures related to work to ensure compliance with cGMP regulations.
• Perform other tasks assigned by department leadership. Qualifications:
• Bachelor’s degree or higher in Pharmacy, Bioengineering, Biochemistry, Chemistry, or a related field.
• Minimum 3 years of QA experience in commercial manufacturing of biologics.
• Proficient in English listening, speaking, reading, and writing – mandatory.
• Strong ability to work under pressure and excellent teamwork and coordination skills.