Responsibilities of Quality Director (1)
1, establish and improve the quality management system and supervise the operation of the system, and implement the quality policy and quality objectives of the group;
2. Responsible for the quality management of the company's products;
3. Control abnormal quality, strengthen quality analysis and improve the quality level of all employees;
4. Promote the quality management system certification;
5. Popularize advanced quality management methods;
6. Be responsible for department construction and management, and ensure the realization of product quality standardization.
7. Complete tasks and work assigned by other superior leaders.
Responsibilities of Quality Director (2)
(1) Establish GMP quality management system in Linping Plant;
(2) According to GMP requirements, participate in the construction of new workshops, conduct quality risk assessment and analysis, conduct effective risk management and formulate relevant documents;
(3) Responsible for the management of production quality GMP documents, and organize the formulation or review of various GMP management documents, systems, standards and operating procedures to ensure the effective implementation of GMP;
(4) Responsible for reviewing all quality-related documents to ensure that relevant materials and products meet the registration requirements and quality standards;
(5) Responsible for ensuring the completion of all necessary confirmation or verification work of the newly-built pharmaceutical factory, and reviewing and approving the confirmation or verification plan and report;
(6) Be responsible for reviewing and receiving relevant quality information of newly listed products, and ensuring that the information provided by R&D meets GMP requirements and is enforceable;
(7) Organizing the declaration, certification and implementation of GMP;
(8) Evaluate, review and approve the supplier quality system of raw materials, packaging materials and other production-related materials;
(9) Accompany and translate foreign clients and foreign auditors (such as WHO, FAD, EU, etc.). );
(10) as the quality authorizer of the company.
Responsibilities of Quality Director (3)
1. Be responsible for establishing the company's quality system and management system and formulating inspection standards;
2. Responsible for the overall quality supervision and management of raw materials, semi-finished products and finished products inspection, and punish violations of relevant quality management systems according to regulations;
3. Responsible for accepting and judging customer complaints, tracing back to the source, finding out the root causes, and formulating measures to prevent recurrence, reducing the customer complaint rate and improving customer satisfaction;
4. Be responsible for the introduction of the company's ISO900 1 quality management system, assist the general manager in internal audit and management review, supervise and guide the system work of various departments, and ensure the normal operation of the company's ISO900 1 management system;
5. Be responsible for team building, personnel training, motivation and assessment of the Quality Department.
Responsibilities of Quality Director (IV)
1. Organize the implementation of medical device supervision and management regulations, relevant medical device regulations and quality management specifications to meet relevant requirements;
2, according to the national medical device laws and regulations and the company's business strategic objectives, presided over the formulation of the company's quality policy, quality objectives, organize the decomposition of quality objectives and supervise the implementation;
3. According to the company's quality policy and strategic objectives, promote the construction of quality management system and organize the operation of quality management system;
4. Responsible for product quality planning, promoting the implementation of quality risk assessment and risk control measures, and supervising the implementation process;
5. Establish and implement a rapid response and notification mechanism for major quality accidents, customer complaints and adverse events, and be responsible for closed-loop handling of quality problems;
6. Understand the product standards and technical requirements, and be responsible for the development of test resources to meet the monitoring requirements and continuous improvement;
7, responsible for product reliability verification plan, and promote the implementation;
8. Be responsible for the internal organizational structure and job responsibilities of quality, and ensure the smooth development of all work in the department.
Responsibilities of Quality Director (5)
1. Establish and improve the quality management system, lead the customer audit, and be responsible for the supplier quality system review.
2, quality indicators, quality management work plan and implementation plan, to ensure the quality indicators.
3. Formulate quality management system and product quality improvement plan to reduce quality cost.
4. Define the quality control activities and methods at each stage of the product/project life cycle, and supervise their implementation.
5. Participate in internal and external feedback processing of product quality, summarize and analyze quality trends, and organize relevant departments to continuously improve and enhance quality capabilities.
6. Responsible for the construction of quality management team and the improvement of quality management ability.
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