1. Objective: To clarify the post responsibilities of the person in charge of the enterprise, ensure the establishment and improvement of the daily operation and quality system, and ensure the drug quality and the safe and effective use of drugs by the masses.
2. Scope of application: applicable to the position of the person in charge of the enterprise.
3. Person in charge: person in charge of the enterprise.
4. Contents:
4. 1 the person in charge of the enterprise is the main person in charge of the drug quality of the enterprise, and is mainly responsible for the drug quality operated by the enterprise.
4.2 Actively study the Drug Administration Law of People's Republic of China (PRC), the Regulations for the Implementation of the Drug Administration Law of People's Republic of China (PRC), and the Quality Management Standards for Drug Trading, organize all employees to study and implement them, and conduct business management under the guiding ideology of quality first to ensure that the business scope of the enterprise is within the legally approved scope and all business activities meet the requirements of national laws and regulations.
4.3 Be responsible for the daily management of the enterprise, create necessary material and technical conditions, and make the business environment and storage conditions meet the quality requirements of drugs.
4.4 Set up and lead quality management personnel and store managers reasonably, correctly handle the relationship between business operation and drug quality management, put drug quality first, actively support and ensure quality management personnel to exercise their functions and powers independently, objectively and effectively, and support quality management personnel to implement quality veto.
4.5 Establish and constantly improve the quality management system and quality documents in operation, be responsible for the approval and release of important documents such as the company's job responsibilities, quality management system and operating procedures, supervise the implementation of the quality management system, and be responsible for the assessment of the implementation of the quality management system.
4.6 Guide and supervise employees to standardize drug business behavior in strict accordance with GSP requirements and quality management documents, take effective measures and rectify existing problems, and reward and punish teams and personnel who have made achievements in drug quality management and violated laws and regulations.
4.7 Be responsible for organizing the investigation and handling of major quality problems and quality accidents.
4.8 Create and spread Tongrentang culture and enterprise spirit, promote the maintenance and coordination of interpersonal relationships, strengthen unity and improve enterprise cohesion.
4.9 Responsible for other work arranged by the superior company.
2 store managers
1. Objective: To clarify the job responsibilities of the store manager and ensure that the company's drug quality and business activities meet the requirements of relevant laws and regulations.
2. Scope of application: applicable to the position of store manager.
3. Person in charge: store manager
4. Content
4. 1 Actively study and implement the Drug Administration Law of People's Republic of China (PRC), the Quality Management Standard for Pharmaceutical Trading and other relevant laws and regulations as well as the company's quality management system, and establish legal awareness and quality awareness. Carry out business management under the guiding ideology of quality first to ensure that all business activities of the company meet the requirements of national laws and regulations.
4.2 Under the leadership of the person-in-charge of the enterprise, entrusted by the person-in-charge of the enterprise, be responsible for the daily management of the enterprise and take the leadership responsibility for the quality of drugs operated by the enterprise.
4.3 Create necessary material and technical conditions to make the business environment and storage conditions meet the quality requirements of drugs.
4.4 Set up quality management personnel reasonably, correctly handle the relationship between enterprise management and drug quality management, give priority to drug quality, actively support the work of quality administrators, and do not obstruct or set obstacles for quality administrators to exercise quality veto power to ensure the exercise of quality veto power.
4.5 Ensure that the company deals in drugs in accordance with the business mode and business scope approved by law, and shall not operate beyond the scope.
4.6 Be responsible for the daily management of store commodity display, sales, service, hygiene and labor discipline.
4.7 Actively listen to the opinions of the quality director on quality management, and take effective measures to improve the existing problems.
4.8 Organize relevant personnel to take stock of commodities regularly to ensure that the accounts are consistent.
4.9 Pay attention to customers' opinions and complaints, and coordinate relevant departments to take effective measures for timely improvement.
4. 10 is responsible for the management of fixed assets, equipment, facilities and network information of the store.
4. 1 1 Responsible for store safety, and urge employees to strictly implement the safety management system and related safety precautions against fire, theft, robbery and fraud.
4. 12 is responsible for the cashier management of stores to ensure the safety of funds.
4. 13 is responsible for the management of drug advertisements in the store, and stops posting and distributing advertisements that have not been approved by relevant departments.
4. 14 Other work arranged by the superior.
3 Quality Director
1. Objective: To clarify the post responsibilities of quality controllers, ensure the establishment and perfection of quality system, and ensure the drug quality and the safe and effective use of drugs by the masses.
2. Scope of application: suitable for quality supervisor positions.
3. Person in charge: person in charge of quality
4. Contents:
4. 1 The person in charge of quality is qualified as a licensed pharmacist and registered in our company, and may not hold part-time jobs, and has not been prohibited from practicing by relevant laws and regulations.
4.2 Earnestly study and implement the Drug Administration Law of People's Republic of China (PRC), the Quality Management Standard for Pharmaceutical Trading and other relevant laws, regulations and policies, and urge relevant departments and post personnel to implement the laws, regulations and quality management standard for pharmaceutical trading.
4.3 Responsible for establishing the quality assurance system for the whole process of business activities such as procurement, sales, storage and after-sales service to ensure the quality of drugs.
4.4 Be responsible for organizing the formulation of quality management documents such as quality management system and operating procedures, and guiding and supervising the implementation of the documents.
4.5 Be responsible for reviewing the qualification certificates of suppliers and their sales personnel; Responsible for reviewing the legality of purchasing drugs.
4.6 Be responsible for drug acceptance management, and guide and supervise the quality management of drug procurement, storage, display and sales.
4.7 Responsible for drug quality inquiry and quality information management, collecting and analyzing drug quality information, and establishing quality information files.
4.8 Responsible for the investigation, handling and reporting of drug quality complaints and quality accidents.
4.9 Responsible for the confirmation and treatment of unqualified drugs.
4. 10 is responsible for reporting counterfeit and inferior drugs and adverse drug reactions.
4. 1 1 To be responsible for educating or training employees in relevant laws and regulations such as the Drug Administration Law of People's Republic of China (PRC), the Quality Management Standard for Pharmaceutical Trading, and the company's quality management system, operating procedures and pharmaceutical professional knowledge.
4. 12 is responsible for reviewing and controlling the operating authority of the computer system and maintaining the basic data of quality management.
4. 13 is responsible for organizing the calibration and verification of measuring instruments, submitting an application for calibration and verification to the metrological department of the jurisdiction in time, and establishing the archives of measuring instruments.
4. 14 to guide and supervise pharmaceutical services.
4. 15 is responsible for establishing the quality files of drugs handled by the company, including quality standards, and making various quality ledgers and records.
4. 16 Conduct regular and irregular inspections on the drug quality management system and implement the system assessment.
4. 17 is responsible for the supervision of drug advertisements in stores and other duties that should be performed by the quality director.
4. 18 timely discover and stop quality violations, and have the right to veto quality:
(1) Reject unqualified drugs;
(2) veto unqualified drugs found in storage, display, maintenance and sales;
(3) veto the company's illegal sales behavior;
(4) Reject unreasonable responsibilities, processes and documents in the quality system;
(5) Reject inappropriate storage environment and unprofessional service.
4 Manager on duty
1. Objective: To clarify the duties of the manager on duty and ensure that the pharmaceutical business activities of the company meet the requirements of relevant laws and regulations.
2. Scope of application: applicable to the duty manager/monitor position.
3. Person in charge: manager/monitor on duty.
4. Contents:
4. 1 Under the leadership of the store manager, assist the store manager in his work and be a good employee and assistant.
4.2 Consciously implement relevant laws and regulations such as the Drug Administration Law of People's Republic of China (PRC), the Quality Management Standard for Pharmaceutical Trading, and various quality management systems formulated by the company.
4.3 Be responsible for the training and assessment of employee service, etiquette and Tongrentang culture, and urge employees to strictly implement service standards and continuously improve service attitude and quality.
4.4 Responsible for handling all kinds of disputes and complaints in the store and actively coordinating with relevant departments.
4.5 Assist the store manager to do a good job in store safety, and implement safety precautions against fire, theft, robbery and fraud.
4.6 Assist the store manager to do a good job in the inventory of goods in the store to ensure that the accounts and goods are consistent.
4.7 Be responsible for checking the gfd and labor discipline of the employees on duty, and criticize, correct and put forward handling opinions in time when problems violating the discipline and management system are found.
4.8 Responsible for the supervision and inspection of employees' daily work flow, to ensure that the shop assistants strictly implement the company's relevant work procedures in their work, and to avoid the situation of selling the wrong medicine, issuing the wrong ticket and collecting the wrong money.
4.9 Responsible for organizing the implementation of health management system and daily health supervision and inspection.
4. 10 Check the customer's suggestion book and drug shortage register in time, and reply and handle the opinions reflected by customers in time.
4. 1 1 Perform other work arranged by the manager.
5 procurement
1. Objective: To clarify the responsibilities of purchasing positions and ensure the legality and quality reliability of drugs purchased by the company.
2. Scope of application: applicable to procurement positions.
3. Person in charge: Buyer
4. Contents:
4. 1 drug buyers have majors in pharmacy or medicine, biology, chemistry, etc. Or a pharmaceutical professional title. The purchaser of Chinese herbal pieces has a technical secondary school degree or above in Chinese medicine, or has a primary title or above in Chinese medicine.
4.2 Earnestly study and implement the Drug Administration Law of People's Republic of China (PRC), the Quality Management Standard for Pharmaceutical Trading and other relevant laws, regulations and policies, and standardize the drug procurement behavior. The work is carried out in strict accordance with the company's procurement management system, the first enterprise and the first variety management system.
4.3 Reasonably design the inventory structure and make a scientific and reasonable purchasing plan. Analyze the market dynamics, organize the supply of goods in time according to the inventory situation, ensure to meet the market demand and maintain a reasonable inventory structure.
4.4 Before purchasing, determine the legal qualification of the supplier, determine the legality of the purchased drugs, verify the legal qualification of the supplier's sales staff, and require relevant qualification examination.
4.5 Understand the supplier's quality assurance capability and participate in the inspection of the supplier's quality assurance system.
4.6 Purchases shall be made in strict accordance with the company's approval procedures for the first camp enterprises and the first camp varieties, and only after being approved by the person in charge of quality and enterprises.
4.7 Business contacts with illegal drug business units are prohibited to ensure that the purchased drugs are qualified in quality and the prices are fair and reasonable.
4.8 It is strictly forbidden to purchase counterfeit drugs and inferior drugs as stipulated in the Drug Administration Law of People's Republic of China (PRC), as well as drugs punished according to counterfeit drugs and inferior drugs. It is forbidden to purchase narcotic drugs, psychotropic drugs of category I, drugs for terminating pregnancy, protein assimilation preparations, peptide hormones (except insulin), pharmaceutical precursor chemicals, radioactive drugs, vaccines and other drugs that are not allowed to be retailed by the state. Psychotropic drugs of category II and toxic drugs for medical use shall not be purchased.
4.9 When purchasing drugs, ask suppliers for invoices.
4. 10 purchasing drugs with special management and drugs with special management requirements of the state shall be strictly implemented in accordance with relevant state regulations.
4. 1 1 Make purchase records and keep them properly.
4. 12 Collect drug quality information, "select the best" and establish customer files. Participate in the overall comprehensive quality review of drug procurement.
6 receiving goods
1. objective: to clarify the responsibilities of the receiving post and ensure that the delivered drugs meet the requirements and the tickets and goods match.
2. Scope of application: applicable to receiving posts.
3. Person in charge: consignee
4. Contents:
4. 1 Earnestly implement the Drug Administration Law of People's Republic of China (PRC), the Quality Management Standard for Pharmaceutical Trading and other relevant national laws and regulations, standardize the receiving operation, and ensure accuracy.
4.2 Carry out drug receiving work in strict accordance with the company's receiving management system.
4.3 Take charge of receiving the returned drugs in the purchase and sale, verify the channels for returning drugs in the purchase and sale, and prevent counterfeit drugs and inferior drugs from entering the company.
4.4 After the drugs arrive, verify whether the transportation mode meets the requirements, and check the drugs with the attached bills (tickets) and purchase records to ensure that the tickets, accounts and goods are consistent.
4.5 After the refrigerated and frozen drugs arrive, the quality control conditions such as transportation mode, temperature records during transportation and transportation time shall be inspected and recorded. Rejection that does not meet the temperature requirements.
4.6 For drugs that meet the acceptance requirements, according to the requirements of variety characteristics, put them in the corresponding areas to be inspected, or set up status signs to inform acceptance.
4.7 Assist in drug fire prevention, theft prevention, insect prevention, rat prevention, pollution prevention and mildew prevention;
4.8 Assist in drug inventory.
7 acceptance
1. Objective: To define the post responsibilities of acceptance and ensure the quality of purchased drugs is qualified.
2. Scope of application: applicable to acceptance posts.
3. Person in charge: inspector.
4. Contents:
4. 1 drug inspector has a degree in pharmacy or medicine, biology, chemistry and other related majors or a professional title in pharmacy. Acceptance personnel of Chinese herbal pieces have technical secondary school degree or above in Chinese medicine, or have primary titles or above in Chinese medicine.
4.2 Seriously study and implement the Drug Administration Law of People's Republic of China (PRC), the Quality Management Standard for Pharmaceutical Trading and other relevant laws, regulations and policies. Carry out drug acceptance in strict accordance with the company's acceptance management system.
4.3 When accepting drugs, the inspection report of the same batch number should be inspected according to the drug batch number, and the inspection report should be stamped with the original seal of the supplier's special seal for quality management, and kept for future reference as required. The inspection report can be transmitted and saved in the form of electronic data, but its legality and effectiveness should be guaranteed.
4.4 For imported drugs, relevant documents shall be checked according to the acceptance procedures.
4.5 For drugs subject to electronic supervision, the electronic supervision code of drugs shall be scanned as required, and the data shall be uploaded to the platform of China drug electronic supervision network system in time. Drugs that do not meet the requirements of electronic supervision shall not be put into storage, and shall be reported to the local drug supervision and administration department when necessary.
4.6 Sampling shall be conducted in strict accordance with the specified standards, acceptance methods and sampling principles.
4.7 In strict accordance with the drug acceptance procedures, the appearance, packaging, labels and instructions of the sampled drugs are inspected and checked one by one.
4.8 The drugs that pass the acceptance shall go through the warehousing formalities.
4.9 Drugs found to have problems shall not be put into storage. Fill in the rejection form, report to the quality controller in time, and notify the buyer.
4. 10 Make acceptance records as required and keep them properly.
4. 1 1 Collect quality information, and cooperate with the quality director to complete the drug quality file.
8 maintenance
1. Objective: To clarify the responsibilities of maintenance posts and ensure the quality of drugs in stock and on display.
2. Scope of application: applicable to maintenance posts.
3. Person in charge: maintenance personnel
4. Contents:
4. 1 Seriously study and implement the Drug Administration Law of People's Republic of China (PRC), the Quality Management Standard for Drug Trading and other relevant laws, regulations and policies.
4.2 Work in strict accordance with the company's drug maintenance management system, and maintain drugs according to storage conditions, external environment and drug quality characteristics.
4.3 Guide and urge the warehouse personnel to store and operate drugs reasonably.