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Overview of quality director's job responsibilities

The quality director needs to have strong organizational, leadership, control and communication skills, strong personality and strong independence. The following are the responsibilities of the quality director that I have carefully collected. I will share it with you and enjoy it together.

Responsibilities of quality director 1

1. Plan, formulate and promote the company's quality assurance policy, quality management process, quality management innovation, etc.

2. Be responsible for the formulation, implementation and revision of the company's quality standards, inspection tools and inspection methods, and ensure effective implementation;

3. Lead the team through the production process and testing to ensure that raw materials, parts and products meet the determined quality standards;

4. Improve the existing quality control methods and processes;

5. Cooperate with managers of other departments to develop new products, new processes and training methods;

6. Prepare product and process quality reports;

7. Ensure the products are qualified, and lock and handle the defective products in time;

8. Approve products according to PPAP process;

9. Work with other departments to develop new suppliers;

10. Responsible for handling customers' quality complaints and complaints;

1 1. Cooperate with the project team to prepare and maintain the PFEMA, cooperate with engineers to effectively connect the PFEMA and DFEMA, and update the PFEMA.

12. Effectively manage and motivate the team to ensure the effective realization of quality performance.

Responsibilities of Quality Director 2

1, responsible for the implementation of the company's quality policy and quality objectives, and improving the company's quality management.

2. Be responsible for the formulation and implementation of various quality management systems of the company, as well as the implementation and promotion of various quality management activities.

3. Be responsible for the formulation and implementation of various quality management systems of the company, as well as the implementation and promotion of various quality management activities.

4 responsible for the formulation and implementation of quality standards and inspection procedures for incoming materials, semi-finished products and finished products, and supervise and guide the quality inspection work.

5. Deal with quality anomalies, assist the investigation and cause analysis of customer complaints and returns, and formulate improvement measures.

6. Organize the control of nonconforming products, formulate preventive and corrective measures for nonconforming products, and supervise their implementation.

7. Responsible for the management of inspection instruments, measuring tools and experimental equipment.

8. Supervise and inspect quality records and organize quality data analysis.

9. Responsible for the collection, transmission and reply of quality management information, as well as the analysis and control of quality cost.

10, responsible for the implementation of the company's total quality management and the internal quality audit of the work of various departments.

1 1. Establish and implement the company's quality management system, and organize the preparation and review of quality documents such as quality manuals.

12. Organize and coordinate the certification of the company's products, and be responsible for the evaluation of raw material suppliers.

13, hold on-site quality work meeting.

14, responsible for the employment and dismissal of employees in this department, as well as the supervision, evaluation and assessment of the work of subordinate employees.

15, complete other work assigned by the factory director.

16. Organize the establishment, maintenance and implementation of the company's quality certification system. And have FDA certification experience.

Responsibilities of Quality Director 3

1, responsible for organizing the establishment and improvement of the quality management system of the company's product production, and monitoring the system to ensure its effective operation. Establish the company's quality risk assessment system to ensure the quality of released products.

2. According to the company's quality objectives, be responsible for organizing the formulation of the company's annual quality action plan and providing technical and regulatory support for all the work involved in achieving the quality objectives.

3. Be fully responsible for and supervise the implementation of the company's quality management activities, and examine and approve various plans, schemes and reports.

4. Be responsible for the formulation, revision, review and approval of internal control standards for raw materials, intermediate products and finished products involved in related products, and ensure that raw materials, packaging materials, intermediate products and finished products meet the requirements of registration approval and Pharmacopoeia standards.

5. Be responsible for the formulation, revision, review and approval of environmental quality standards for process water and clean area, and ensure that process water and clean area environment meet GMP requirements.

6. Be responsible for reviewing and approving quality standards, process regulations, GMP-related management documents, sampling methods and inspection methods, production and inspection operation procedures, etc. To ensure that the production process of products meets GMP requirements.

7, responsible for organizing personnel to supervise and inspect the quality management activities of various departments, including material procurement, product quality inspection, quality supervision of the whole production process, product storage and transportation, etc.

8. Responsible for reviewing and approving all quality-related deviations, changes, OOS/OOT, etc. , to ensure that the production is carried out in accordance with the approved registration process, and to ensure that all major deviations and over-standard conditions are investigated and handled in time.

9. Approve and supervise the entrusted inspection; Supervise the maintenance of factories and equipment to keep them in good working condition; Determine and monitor the storage and transportation conditions of materials and products.

10, to ensure the completion of self-inspection and all necessary confirmation and verification; Evaluate and approve material suppliers.

1 1. Ensure the continuous stability inspection plan of products is completed, and provide stability inspection data and analysis report.

12. Participate in activities that have a key impact on product quality, and exercise veto power over the selection of key material suppliers and key production equipment, as well as the selection of key personnel in production, quality, procurement and equipment departments.

13, responsible for communication and coordination with market supervision and management departments.

14. Supervise the implementation of quality system and participate in self-inspection and rectification. Conduct risk assessment on production and quality system, and monitor various factors affecting product quality.

Responsibilities of Quality Director 4

1, responsible for establishing the quality management system of four factories, and supervising the achievement of the objectives of the functional departments of each factory;

2, the formulation and implementation of quality system, internal and external system audit, customer audit preview, response, improve quality standards and requirements;

3. Quality monitoring and abnormal judgment/handling in the manufacturing process;

4, collaborative technology, mold, biotechnology, die casting, processing (post-processing), numerical control processing, procurement outsourcing, etc. Do a good job in product project development and process supervision, reduce quality anomalies in the development process and reduce development costs;

5. Supplier quality audit, customer complaint handling supervision, investigation, reply, 8D report, and exception list closing;

6, department personnel management, team building (project, process, full inspection, import and export/raw materials, laboratory, GP12);

Responsibilities of Quality Director 5

1, fully presiding over the work of the quality management department, and responsible for formulating the management objectives of this department;

2. Organize and promote the company's quality management and establish the company's quality management and control system;

3. Be responsible for establishing the company's product quality control guarantee mechanism;

4. Organize and promote the construction and improvement of quality management system, laboratory accreditation and measurement management system;

5, responsible for establishing quality analysis and quality improvement management mechanism;

6. Overall planning of the work of the quality management department, and reasonable arrangement of the work content of the personnel in this department;

7. Responsible for personnel training and team building within the department;

8, complete other work assigned by the leadership.

Responsibilities of Quality Director 6

1. Enterprise Quality Authorized Person.

2. Responsible for GMP certification of the whole company.

3. Establish and improve the quality management system, check the operation of the production quality system, and put forward suggestions for continuous improvement.

4 responsible for internal self-inspection, external audit, adverse drug reaction report, product recall and other quality management activities.

5. Responsible for the release of batch products.

6. Approve quality standards, sampling methods, verification and other quality management operating procedures.

7. Review and approve deviations, changes and OOS investigations.

8. Assist the general manager in quality planning, organize and supervise the company's quality planning, implementation and budget.

Responsibilities of Quality Director 7

1. Be responsible for the overall planning and implementation of the quality system in the whole product realization process (including customer requirements, design and development, pilot test, incoming materials, manufacturing process, delivery, customer complaints, improvement, etc.) (including the establishment of relevant systems, processes and standards). ) and organize the implementation;

2. Responsible for the quality system audit of customers and third parties, and report the quality status to the management and customers;

3. Supervise the implementation of the company's product quality improvement and scheme improvement, maintain the company's quality assurance system and improve product quality;

4. Be responsible for the establishment, implementation, certification and maintenance of the quality management system (TS 16949). ISO 900 1。 ISO 1400 1。 OHSAS 1800 1。 );

5. Responsible for handling, analyzing, correcting and preventing nonconformities found in production and inspection, as well as quality complaints from internal and external customers;

6. Responsible for building a quality management team with high quality and high combat effectiveness;

7. Be responsible for the construction of the company's quality culture and improve the company's quality management ability and level.

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