Summary of quality assurance work in pharmaceutical factory

Summary of quality assurance work in pharmaceutical factory

Time flies, and the years are like songs. In the blink of an eye, 20xx years have quietly ended. We are about to enter a brand-new 20 14 year, looking back at 20 13 years. Under the leadership of the chairman of the group company, the economic and social benefits of Yizheng Group have made great progress compared with the previous year, and it is under this good opportunity that I entered this big family. From mid-May to now, I have been working in the pill workshop for seven months. Although seven months of light and shadow can't cultivate a firm belief, I have gained a lot of care and help from my superiors and colleagues around me. I want to say thank you to them here, and I have improved my business level significantly through my own efforts. Therefore, I finished my work brilliantly. During this period of work, I realized that I am working happily, living happily, working hard for my life goals, and my personal thoughts are becoming more and more mature. Summarizing the past can help us explore the future better. "The road I have traveled is like iron, but now I am striding forward from the beginning." At this time, it is necessary for me to make a serious summary of my work in the past year in order to make myself do this. To a great cause. "The following is a summary of my 20xx annual work.

First, improve their own quality and strive to adapt to the working environment.

After coming to work in the company, in order to meet the needs of QA work, I always put learning business knowledge in the first place to improve my special quality in management, so that I can gradually become a qualified management talent, communicate with colleagues and help others, so that I can quickly integrate into the company team. On the other hand, I strictly abide by the company's rules and regulations, don't be late, don't leave early, and actively participate in various activities, trainings and workshops held or organized by the company. (such as GMP, enterprise management related training, Siping City Federation of Trade Unions, etc.). ). Through GMP training, my GMP knowledge has been enriched, which is more conducive to the effective development of my own QA work, and the quality and efficiency of all work have been significantly improved.

Second, carefully monitor the production process and implement quality assurance.

One of the main contents of QA job responsibilities is the on-site monitoring of production process. Every morning, after I come to the company, I will monitor the production process in real time in the following steps according to my post.

1. Check whether all the equipment and main entrances at the production site of each post have status labels, check whether the intermediate products stored in the intermediate station have intermediate product labels indicating the material name and flow direction, and whether the posts and equipment that are temporarily not produced have cleaning labels and are within the cleaning validity period.

2. After weighing and batching, check whether the name, specification and weight of raw materials are consistent with the production instructions of this batch, whether the liquid level of each weighing instrument is zero, and conduct dual-core alignment.

3. Mixing position: Check whether the hardness, uniformity and color of the mixed particles are consistent.

4. Pilling and cutting post: check whether the pill weight is within the range of internal control standards and whether the pill shape is round.

5. Drying post: whether the temperature and drying time of the fluidized bed meet the requirements, and whether the moisture and temperature meet the process requirements.

6. Coating post: check the receiving and coating materials of batch production instructions, and check the appearance of pills, whether they are round and uniform, and whether the colors are consistent when coating. Ensure that the appearance and weight difference of production varieties meet the company's internal control standards;

7. Aluminum-plastic packaging post: check whether the appearance of the medicine board is accurate, whether the board surface is clean, whether the joints are tight, and whether the production batch number and validity period are consistent with the batch production instructions.

8. Packaging post: check whether the batch number, production date and expiration date of the drug are consistent with the batch packaging instructions, and conduct spot checks on the packaging site. Whether the packing quantity is accurate and the packing list is correct.

In the process of on-site supervision and inspection of each post, if it is found that the site does not meet GMP requirements, it will promptly notify the post monitor or relevant personnel to correct it. When quality problems are found, report to superior leaders in time and coordinate to solve them.

Three. Work closely with technician * * * to complete the verification of workshop equipment cleanliness, document revision and batch production record review.

The audit of batch production records is also one of my priorities. Up to 20xx65438+February1February 02, batch production records of various varieties 1 17 have been reviewed, including filling in customs clearance certificates, monitoring records of production process, checking whether the data in the records are accurate, consistent with batch production instructions and packaging instructions, and whether the records are complete. In addition, due to the need of new GMP certification, I cooperated with technician Li Mo to complete the revision of 36 documents in two parts: equipment cleaning verification and equipment confirmation. The verification plan and verification report are mainly arranged to ensure the reliability, accuracy and reproducibility of the above projects in the course of work.

Fourth, cooperate with the sales department to complete the preparation and reporting of monthly sales records.

At the end of each month, according to the sales data provided by the sales department, complete the preparation of sales records and report them to the quality management department. By the end of February, 65438+, I had finished the preparation and report of seven months' sales records.

Five, complete the clean area temperature and humidity, dust ion detection and data statistics filing.

According to the new GMP certification requirements, the quality management department revised the new template of temperature and humidity records in clean areas. The 7-month work of temperature and humidity, dust ion records and data statistics completed from May to 65438+February was combined with the records of settling bacteria provided by the central laboratory and submitted to the quality management department for the record.

Six, according to the scheduling with the central laboratory to complete the sampling work in the production process.

As of February 23rd, 65,438 * * 237 samples of various kinds of intermediate products, products to be packaged and finished products have been completed. After the samples pass the inspection, the central laboratory will provide the inspection report. Sixth, other parties complete other temporary work arranged by the factory director according to the deployment of workshop leaders. Mainly manifested as: the preparation of workshop internal situation description and personnel statistics and other temporary work.

The above six aspects are the contents of my work in the second half of 20xx. Through continuous study and exploration, I have seen my own advantages, I am hardworking, willing to work and not afraid of hardship. Positive working attitude and strong pressure resistance are my motivation for this job. Of course, I also have my shortcomings. This can be summarized as follows:

1, insufficient communication with workshop leaders, sometimes unable to understand the real wishes expressed by the supervisor, leading to thankless work.

2. Management ability needs to be strengthened, because my previous work rarely involved management, so I think my management ability has a relatively large room for improvement after I came to the company. As the teacher said, management is an art, which encourages employees actively, trusts employees and lets them go. The purpose is to give full play to the subjective initiative of the squad leaders and employees in each position, so that they can perform their duties and make fewer mistakes when dealing with problems.

3. Insufficient workflow. Sometimes I don't know which one I should do at work, or I should arrange a workshop position to do it. For example, fill in personal work records. On the other hand, you will have endless work in your hands. Can't achieve the result you want. I think I should learn from Secretary Jiu Duan. The year before last, I had the honor to participate in an executive training, during which I commented on the highest realm of Secretary Jiu Duan. At work, I need to be active at all times, standardize and standardize the seemingly disorderly work, and complete every link according to the standardized process every day in order to achieve satisfactory results for myself and my superiors.

If you don't accumulate steps, you will be thousands of miles away; If you don't accumulate trifles, you can't turn rivers into oceans. Summing up the past is to look forward to the future better. In the new year, I will redouble my efforts to learn business knowledge, production technology and improve management level, so that I can gradually move towards compound talents. The following is my work plan for 20xx years.