Job Responsibilities:
1. Assist the quality management manager in planning, establishing, implementing, supervising, and continuously improving the quality management system of the entire company; And promote the company's annual and medium - to long-term quality goals, quality policies, and quality plans;
2. Ensure the quality, safety, and effectiveness of all products (R&D, clinical, and marketing);
3. Responsible for the budget preparation, resource planning, personnel selection, and training of the QA department, ensuring that the department has the ability to fulfill its responsibilities;
4. Responsible for quality monitoring of the entire production process of products in accordance with relevant laws and regulations such as biological products, and responsible for final release review and market release review of products;
5. Responsible for reviewing and approving key deviations and major changes, evaluating the comprehensive impact of major deviations and changes on product quality, process validation, and regulatory registration;
6. Responsible for reviewing enterprise self inspection, monitoring and reporting of adverse events, product recalls, quality risk assessment reports, qualified supplier catalogs, etc;
7. Responsible for handling, reviewing, and tracking quality complaints, returns and exchanges, and non-conforming products;
8. Responsible for verification management, reviewing verification plans, reviewing verification schemes and reports;
9. Organize the formulation and improvement of quality standards for raw materials, packaging materials, intermediate products, and finished products;
10. Provide comprehensive GMP system support documents for drug marketing authorization applications, change declarations, etc., and ensure that the production site complies with the registration document description.
Qualification:
1. Bachelor's degree or above in biology, pharmaceuticals, drug analysis, pharmacy or related majors;
2. At least 15 years of practical experience in the production and quality management of biological products, including at least 2 years of work experience in the same position. Priority will be given to those who meet the above conditions and have experience in both cell therapy product quality management and research and development quality management.
3. Familiar with drug research and development, product registration, clinical practice, GMP management requirements, familiar with ICH guidelines, and able to systematically integrate them into the quality management system;
4. Deeply understand the requirements for data integrity, drug vigilance, drug registration, and GMP integration;
5. Having practical experience in successfully responding to GMP on-site inspections;
6. Have communication skills, be diligent and responsible, adhere to principles, be patient and meticulous, and possess a sense of teamwork.
After joining this position, there will be a brief business trip to Kunming to familiarize oneself with the work for about a month. If you mind, do not apply