Quality Manager

1 person, master degree or above, more than 3 years working experience

Job description:

1. Quality management: establish and maintain the company's GMP quality management system; Implement, supervise and implement enterprise quality policy and quality target; review and approve the release of raw materials and finished products; organize to formulate and supervise the implementation of inspection standards for raw materials, semi-finished products, and finished products; Participate in the assessment and evaluation of raw material suppliers and outsourcing processors; Establish a sound company quality management system and workflow, and organize implementation and supervision; organize and implement equipment management, tracking, deviation, calibration, verification, etc .; Handling and tracking of quality anomalies, analysis and reporting of causes of poor quality; responsible for the quality management training of all employees of the company and participating in risk management;

2. Document management: company controlled document management, regular supervision and inspection, timely organization and revision of unsuitable documents; collection, distribution, instruction and publicity of foreign documents such as biological products, cell preparation industry regulations, national standards, business standards, etc .; review quality and technical standard documents; review and issuance of bidding and qualification certificates; standard management, preservation and update of company archived documents; review of compliance with various specifications;

3. Quality certification product registration qualification declaration: GMP quality management system external audit, internal audit;

4. Maintenance of public relations: coordination of on-site inspection work by superior competent authorities; establishment and maintenance of the relationship between testing agencies and certification agencies;

5. Department management: department personnel management, business guidance, training and assessment; coordination and communication with other departments.


Job requirements:

1. Medicine, biology, biochemistry, microbiology, immunology, pharmacy and other related professional college degree or above, master degree or above is preferred, Training or experience in quality control, production management or registration certification;

2. At least 3 years of working experience in bioproducts-related production enterprises; working experience in cell drug development, testing, and registration is preferred;

3. Ability to manage positions in competent departments;

4. Familiar with quality management work flow, with experience in establishing quality department management system is preferred;

5. Proficient in the knowledge of biological preparations, cell products and production process technology application;

6. Familiar with professional knowledge of international quality system;

7. Familiar with national laws, regulations and industry policies;

8. Good English reading and comprehension skills; strong learning, analysis, understanding, communication and coordination skills.