QA 主管/经理 QA Manager / Director

岗位职责:
QA Manager / Director Duties and Responsibilities1. Assure compliance of APIs manufacturing with cGMP； 2. Manage the validation program for processes, cleaning, equipment, utilities, facilities, and computer systems, as well as stability programs； 3. Responsible for review and approval of laboratory OOSs and manufacturing deviations and investigations； 4. Provide internal and external auditing； 5. CAPA and management reviews； 6. Carry out performance reviews with QA personnel in accordance with the Company performance management system；7. Ensure that all GMP related documentation is regularly reviewed and updated in accordance with Company policy；8. Review and approve product quality review reports；9. Plan and ensure delivery of training and on-going development for QA personnel.

Requirements1. Bachelor’s degree or advanced degree in a science, engineering, or related field；2. Thorough knowledge of cGMP；3. At least five years experience in implementing or maintaining compliant quality systems；4. At least three years experience in a FDA and/or EDQM approved API Facility； 5. Have excellent interpersonal, problem solving, and communication skills；6. Ability to read and speak English.