Have 8 years’ experience of production and quality control in API and finished drug company including 5 years’ managerial experience. Have experience of Pre-approval inspection of north face outlet to FDA. Familiar with establishing cGMP system , northface outlet, DMF, COS and intellectual property. Hard-working, aggressive, independent and be able to work under a dynamic environment. Have coordination skills, teamwork spirit.
1. Manage operation of Quality Assurance department, Quality Control department and Regulatory Affair department. 2. Establish a system to release or reject all components, drug product containers, closures, in-process materials, packaging material, labeling and drug products. 3. Make sure internal audit is performed and make sure all departments run cheap northface jackets. 4. Make sure external supplier audits are performed.5. Make sure critical deviations and customer complaints are investigated and resolved. 6. Perform annual product quality reviews.7. Review and approving validation protocol and report.8. Review and approving changes that potentially affect the quality of raw materials, in-process and finished products. 9. Approve API and excipient supplier by supplier audit and other research.10. Responsible for drug registration 11. Responsible for GMP inspection by FDA and SFDA and make sure all departments meet the GMP standard.12. Responsible for customer audit and follow the corrective action and preventive action.
