What qualifications do you need to be in charge of quality in a pharmaceutical company?

The requirements of the person in charge of quality of the pharmaceutical factory are as follows:

1. The person in charge of production and quality management of the enterprise shall have a college degree or above in medicine or related majors, and have experience in drug production and quality management, and shall be responsible for the implementation of this specification and product quality.

2. The person in charge of production and quality management of biological product production enterprises should have corresponding professional knowledge (bacteriology, virology, biology, molecular biology, biochemistry, immunology, medicine, pharmacy, etc.), and have rich practical experience to ensure that they perform their duties in production and quality management.

3. The person in charge of drug production and quality management of the Chinese medicine preparation production enterprise should have professional knowledge of traditional Chinese medicine.

4. The person in charge of the production management and quality management department should have a college degree or above in medicine or related majors, and have practical experience in drug production and quality management, and have the ability to make correct judgments and deal with practical problems in drug production and quality management.

The main difference between the person in charge of the enterprise and the person in charge of the quality of the closed search of the pharmacy is that the scope of responsibility of the two is different. The person in charge of the enterprise is responsible for the whole enterprise, he needs to consider the development of the enterprise, and the collapse also needs to consider the profits of the enterprise, and also the employees of the enterprise. The person in charge of the quality of the pharmacy is only responsible for the quality of the product, and he has no right to manage other aspects, so the right is relatively small.

The main person in charge of drug quality is the person in charge of the enterprise.

Drug indicators: 1. Physical indicators: the content of active ingredients and excipients, the weight and appearance of preparations.

2. Chemical indicators: chemical and biochemical of active ingredients in the drug stool.

characteristics and other indicators.

3. Biopharmaceutical indicators: disintegration, dissolution, absorption, distribution, metabolism, excretion and other indicators of drugs.

4. Safety indicators: "consistency", toxicity and adverse reactions of drugs.

and ***, drug interactions and compatibility, contraindications and other indicators.

5. Effectiveness index: the effective degree index of the drug under the specified usage and dosage conditions for the specified indications.

6. Stability index: the index of maintaining the stability of physical, chemical and biological pharmaceutics, safety and effectiveness of the drug under the specified storage conditions and within the specified validity period.

The head of the enterprise must be a natural person, a verbal and, in general, a legal representative of a small company.

It is the person in charge, and if things can't be managed, you can also designate multiple people. The specific person in charge is responsible for the relevant responsibilities and assumes the corresponding responsibilities, such as the general manager, the project leader, the quality leader, the production leader, the chief engineer, the deputy chief engineer and so on. If the liability incurred is not related to a specific person in charge, it may not be held liable.

Legal Analysis: A legal person is an organization that has the capacity for civil rights and civil conduct, and independently enjoys civil rights and bears civil obligations in accordance with the law. As the legal representative, he must be the person in charge of the legal person organization and be able to exercise his or her powers on behalf of the legal person.

The legal representative may be the director and manager of the factory, or the chairman of the board of directors and the chairman of the board of directors. The person in charge of the enterprise is one of the registration items of the business unit and its branches. The person in charge refers to the person who exercises authority on behalf of the business unit and its branches, and presides over the production, operation or service activities of the business unit and its branches.

Generally, it is appointed by the superior legal entity (enterprise legal person, company or legal person of Luyin public institution, social organization legal person, etc.) to which the business unit or branch is subordinate.

Legal basis: Company Law of the People's Republic of China Article 3 The company is an enterprise legal person, has independent legal person property, and enjoys the property rights of legal person. The company is liable for the company's debts with all its property.

The shareholders of a limited liability company are liable to the company to the extent of their subscribed capital contributions; The shareholders of the shares are liable to the company to the extent of the shares they subscribe.

1. The person in charge of the quality of the wholesale enterprise must be a licensed pharmacist who is registered in place; 2. His academic background is a bachelor's degree, and his major must be matched when he is imitated; 3. More than three years of experience in quality management of pharmaceutical business. This sentence is still not exhausted, there are words in the words, a young licensed pharmacist, who has not worked in the quality department for three years, and has not served as the quality manager and quality management personnel of the good bureau in a retail pharmacy or retail chain pharmacy for three years, theoretically cannot take on this position.