Why does the new GSP require that the person in charge of the enterprise must be a licensed pharmacist? Is it okay to hire someone from outside? Is there a difference between the person in charge of a

Why does the new GSP require that the person in charge of the enterprise must be a licensed pharmacist? Is it okay to hire someone from outside? Is there a difference between the person in charge of an enterprise and the person in charge of quality? Can be hired externally.

The requirement that the person in charge of an enterprise is a licensed pharmacist is aimed at retail enterprises. It has solved the problem that the quality director is not on the job that has been difficult to solve for many years. In larger enterprises, the person in charge of the enterprise is hired from outside, so the person in charge of the pharmacy can also be hired from outside, but since he is the person in charge of the enterprise, he will decide everything from procurement to sales.

According to the "Good Quality Management Standard for Pharmaceutical Trading"

Article 122 The person in charge of an enterprise is the main person in charge of drug quality, responsible for the daily management of the enterprise, and responsible for providing necessary conditions to ensure that the quality management department and quality management personnel effectively perform their duties and ensure that the enterprise deals in drugs in accordance with the requirements of this specification.

Difference:

1, different functions and powers

The person in charge of quality shall be the senior management personnel of the enterprise, be fully responsible for drug quality management, perform their duties independently, and have the power of adjudication on drug quality management within the enterprise.

The person in charge is responsible for relevant duties and assumes corresponding responsibilities, such as general manager, project leader, quality leader and production leader. If the responsibility has nothing to do with the specific person in charge, you don't have to bear the responsibility.

2. Different educational requirements

According to the "Good Quality Management Standard for Pharmaceutical Trading"

Article 19 The person-in-charge of an enterprise shall have a college degree or above or an intermediate title, have been trained in basic knowledge of pharmacy, and be familiar with relevant laws and regulations on drug administration and this specification.

Article 20 The person in charge of enterprise quality shall have a bachelor's degree or above, the qualification of licensed pharmacist and more than 3 years' experience in quality management of pharmaceutical business, and have the ability to correctly judge and ensure implementation in quality management.

3. Different responsibilities

Person in charge of quality:

1. For the first enterprise and the first variety involved in the procurement, the procurement department shall fill in the relevant application form, which shall be reviewed and approved by the quality management department and the person in charge of enterprise quality. When necessary, organize on-site investigation to evaluate the supplier's quality management system. ?

2. The person in charge of enterprise quality is responsible for the supervision, guidance, coordination and approval of verification. ?

3. The verification scheme can be implemented only after it is approved by the person in charge of enterprise quality. ?

4. The verification report shall be reviewed and approved by the quality director.

Person in charge of enterprise

1. Under the leadership of the board of directors, during the term of office, abide by the national laws and regulations and the provisions of the competent departments of the industry, practice according to law, be responsible for or report to the board of directors and the shareholders' meeting, and ensure that the return on investment of shareholders is not lower than the social average return;

2. Adhere to the principles of independence, objectivity and impartiality, provide honest services, and ensure the correct direction of the development of this enterprise. With the authorization of the shareholders' meeting, it can invest abroad or adjust the development direction of the enterprise, and absorb other partners after investigation and negotiation or formation of intention for approval;

3, presided over the formulation and implementation of enterprise development planning, talent development planning, various rules and regulations and major corporate decisions;

4. Sign various contracts, agreements and contracts at home and abroad on behalf of the enterprise, or partially authorize others to initial them, and then sign and approve them when conditions permit. Strictly guard against enterprise risks and safeguard the legitimate rights and interests of enterprises;

5, who is also the technical director of the enterprise, and issues a report on major consulting results on behalf of the enterprise (settlement audit, pre-tender estimate, bidding agency with more than 5 million yuan or special projects).

6. Serving as the person in charge of the enterprise market or entrusting an agent to conduct market expansion, business contact and contract terms negotiation in the name of the enterprise, or having the right to form a letter of intent, and organize the initial contract work after the technical, economic and responsible person of the enterprise agrees;

7. Preside over or authorize the technical director or project director to consult on major business projects and decide on the handling of major decision-making issues, business quality issues and risk issues in practice;

8, coordinate and deal with the interests of various departments and employees in the enterprise, and cultivate enterprise team spirit;

9. Represent the enterprise or entrust an agent as plaintiff and defendant to appear in court or handle relevant disputes and disputes on behalf of the enterprise, and coordinate and contact with government departments;

10, leading the organization to deal with emergencies and leading the formulation and implementation of emergency plans;

1 1. Organize the annual inspection of enterprises and declare the qualification upgrade;

12, concurrently in charge of the examination and approval of fees within 3,000 yuan, proposing or examining and approving the consulting fee standard, fee amount or price, major financial revenue and expenditure and distribution methods of the enterprise according to the regulations, and organizing the implementation after reporting to the shareholders' meeting for approval.

13. Put forward or approve personnel appointment and dismissal, rewards and punishments, recruitment, dismissal and other matters according to regulations, and have the right to order the deputy responsible person and other responsible persons at all levels to immediately change their instructions or behaviors for any work-related behavior, and take responsibility or risks for the consequences of their own instructions and actual implementation;

14. The immediate superior is the board of directors. When there is disagreement with the board of directors, efforts should be made to persuade the shareholders' meeting.

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Baidu Encyclopedia-Person in Charge of Enterprise

Traceability System of National Important Products —— Quality Management Standard for Pharmaceutical Business