Tuyển dụng QA Manager (Dược/Vacxin|Long An)

- Quality Management System
- Ensure all operations in the factory are carried out in accordance with GMP requirements.
- Establish, organize, maintain and continuously improve the factory's quality management system.
- Organize to implement the external audit on material suppliers/manufacturers use in the manufacturing and testing.
- To review and approve for all technical documents relating to the quality assurance for products and manufacturing activities of the factory.
- Consult the Board of Directors on technical issues related to the quality.
- Define, maintain, improve and approve analytical methods and specifications by appropriate validation in cooperation with Quality Control Department (if necessary).
- Responsible to have the process and equipment qualification & validations done regularly with approving/ releasing qualification/ validations
- Co-ordination of Internal Audit with relevant departments and initiation and documented follow up of possible corrective action.
- Product quality assurance
- Review and approve for batch record.
- Accept, reject incoming batches of raw materials/packaging before use in production.
- Co-ordination of customer complaint handling investigation with relevant departments, initiation and documented follow up of corrective actions and preventive actions.
- Assure the control on product’s quality in comply with the approved specifications.
- Coordinate with Production and other departments to investigate all deviations, propose corrective and preventive actions. Monitor and support to implement these progresses.
- Personnel management
- Manage, direct, motivate and develop all employees, ensure recruitment, management, training and motivation of employees according to internal procedures, policies and labor laws.
- To ensure that the initial and ongoing training required for staff of QA department is carried out and adapted as needed.
Yêu cầu công việc
- Required qualifications
- University degree or higher in pharmaceutical, biological or related sectors.
- Required working experience
- At least 10 years of experience at position as quality management in the pharmaceutical, injectable or vaccine factory.
- Required languages
- Good English skill.
- Required knowledge and skills
- Proficiency in office information.
- Knowledge of biological drugs or sterile products and vaccines production, and quality assurance.
- Being train and well-informed about the GMP, GLP, GSP.
- Overview capability for the whole system of production and quality control
- Knowledge and experience in the validation fields as facilities, production and laboratory equipment, utilities, manufacturing process and testing ...
- Professional and confident working style.
- Proactive, ability to withstand work pressure.
- Training employee evaluation.
- Management skill.
- Inspection skill.
- Show courage, responsibility, proactively resolve quality issues quickly and appropriately, do not avoid or rely on others.
- Work with a high spirit of service, solve quickly, satisfactorily complete the tasks assigned.
- Fairly, vigorously fight against behaviors that are inconsistent with the Company's regulations in the spirit of solidarity to correct errors.
Quyền lợi được hưởng
- Work in a professional, modern, and safe healthcare environment with excellent opportunities for career development.
- Insurance coverage and annual leave in accordance with the Labor Law.
- Other benefits including periodic health check-ups, holiday and Tet bonuses, birthday gifts/bonuses, etc.