Website Kanghong Pharmaceutical
Deputy General Manager of Quality
Facility Construction Phase:
1、In accordance with overall project plan, set up and improve the quality assurance system.
2、In accordance with overall project plan, oversee the qualification and validation activities to minimize future operational risks.
3、Lead laboratory design efforts in a systematic way and provide technical guidance to minimize the operational risk in laboratory.
4、Organize laboratory LIMS system design and coordinate with various departments to ensure the timely achievement of project goals.
5、Assist the general manager in providing independent quality related guidance for each functional area during facility construction, including drawings development, URS review, system installation and acceptance, etc., Leading to a highly efficient quality system during normal operations.
Normal Production and Operation Phase:
1、Monitor key quality impacted activities in production and operations processes, including material procurement, manufacturing, post marketing support, etc.
2、Be responsible for the establishment, optimization and improvement of quality system to ensure the implementation meets the cGMP standards.
3、Setup annual quality working plan, continuously enhance quality standards and product stability, and participate in overall budget control.
4、Lead risk management activities, identify potential product quality and system risks through trend analysis or other methods, and oversee the implementation of relevant corrective and control measures.
5、Monitor factors affecting product quality and proper record retention, complete self audits, review batch records, and make product release decision.
6、Provide guidance for solving quality-related issues to ensure that solutions are aligned with internal quality standards and the best practices in the industry.
7、Plan and implement initiatives to promote the quality awareness in all staff, consistently improve the company’s overall level of quality control.
8、Build quality management teams and actively develop team members.
1、Bachelor degree or above in bioengineering or related majors.10+ years of working experience in biopharmaceutical manufacture, technology, quality and other departments.5+ years of working experience in biopharmaceutical production management at a commercial scale.
2、Working experience in overseas biopharmaceutical industry is preferred.
3、Expert in GMP management, familiar with US and EU cGMP regulations and biopharmaceutical manufacture procedures and quality standards.
4、Proficient in various risk assessment tools, inspection techniques, and team supervision.
5、Can work rigorously and stick to principles, possess strong decision-making and general management skills.