1 Obey the leadership of the person in charge of production, conscientiously implement the factory rules and regulations, manage the workshop in strict accordance with GMP standards, be responsible for the production management, quality management and administrative management of the workshop, complete all tasks assigned by the company, and take leadership responsibility for all problems in the workshop.
2. According to the issued production plan, reasonably arrange the staffing of each post in the workshop and the preparation before production, carry out production in strict accordance with the process requirements, have the ability to solve problems, eliminate the factors restricting production, ensure the continuous operation of production, complete production tasks, and be responsible for the quality, output and finished product rate of the produced products.
According to the production plan, make overall arrangements for the daily production and personnel of the workshop, so as to ensure the coordinated production of each post, prevent the waste of personnel, equipment, materials and time caused by improper management, and have the responsibility to reduce the production cost on the premise of ensuring the yield (finished product rate) and quality.
4. According to the weight of the production task, flexibly adjust the staffing of production quotas and each post, so that the staff of each post can exert their maximum potential and produce at full capacity, and at the same time embody the principle of more work and more pay.
Responsible for staff training to ensure pertinence, timeliness and effectiveness.
5. 1 Conduct pre-job training for new employees. Including the company's rules and regulations, job responsibilities, work system, safety knowledge and related equipment operation. Combine theory with practice. New employees can only take up their posts after passing the exam.
5.2 According to the monthly training plan, conduct training and assessment for all employees in the workshop.
6. Be responsible for the quality management of workshop personnel and do a good job in the ideological work of employees.
6. 1 Understand the ideological trends of employees and educate and train workshop employees. Publicize the company's principles and policies, thoroughly implement the company's various systems, stabilize people's hearts, unite as one, and ensure safe and civilized production.
6.2 Communicate with employees frequently to understand their working attitude and living conditions, and solve the problems reflected by employees in time. For problems beyond their own ability, they should report to the competent leader in time, and inform the employees in time after solving them, and must not be ignored, delayed or perfunctory.
6.3 Adopt employees' reasonable suggestions to stimulate employees' work enthusiasm.
6.4 Educate employees not to do anything that harms the honor and interests of the workshop and the company.
7. Responsible for the hardware and software work of GMP certification inspection in the workshop and other inspections at all levels;
7. 1 Before the inspection, organize personnel to conduct self-inspection on the software and hardware, timely organize rectification for the problems found in the self-inspection, and check the implementation effect of the rectification. If there are any problems that cannot be solved, report to the person in charge of production in time.
7.2 During the inspection, accompany the inspectors, make preparations and explanations for the software and hardware inspection, and immediately report any unclear problems or questions questioned by the inspectors to the person in charge of production or quality to ensure that the problems are solved in time.
7.3 After the inspection, organize personnel to carry out rectification according to the questions raised by inspectors, draft the rectification report, and check the implementation effect of rectification.
Familiar with GMP terminology, review all kinds of GMP documents and records.
8. 1 Responsible for organizing the preparation, revision, distribution and supervision of various documents in the workshop (including personnel responsibilities, process regulations, post operation SOP, cleaning SOP, verification and confirmation, production master records and auxiliary records) to ensure that the contents of the documents are consistent with production and operable.
8.2 Be responsible for reviewing the batch packing instruction and quota picking list drawn up by technicians in this workshop, and issue them after verification.
8.3 Be responsible for reviewing the batch production records submitted by workshop software engineers, sign the production records after verification and submit them to the Quality Management Department.
8.4 Ensure that records are filed accurately and timely before 7th of each month. If it cannot be filed, explain the reasons.
What you must do every day.
9. 1 patrol inside and outside the workshop at least once a day, and patrol personnel, sanitation, factory buildings, facilities, equipment, water, electricity and gas from the common area under the jurisdiction of the workshop, and solve problems in time when found.
9. 1. 1 Check the production site safety, process execution, product quality, GMP execution, personnel operation, post hygiene and common area hygiene of each post.
9. 1.2 Check whether the employees comply with the factory rules and regulations, operating procedures and the production progress of the workshop.
9. 1.3 is responsible for solving the problems that restrict production in all aspects of production, handling the problems on the same day when they are found, and reporting the problems that cannot be handled to the manager of production management department or the person in charge of production in time on the same day, and studying with leaders to determine the solutions and implementing them. ?
9.2 Report the production completion and abnormal situation of the workshop to the person in charge of production every day, and ask the leaders for instructions on the next stage of production arrangement and production tasks.
9.3 Review the daily production report to ensure that the data is true and accurate.
10 What you must do every week: Organize a regular workshop meeting, including:
10. 1 Summarize last week's production, completion and existing problems.
10.2 Arrange the production task for next week and discuss with employees how to improve the product quality and ensure the yield.
10.3 Train employees in various systems such as record filling, equipment operation, cleaning and sanitation.
10.4 implement the spirit of the company meeting, emphasize the importance of safe production, and conduct safety training for employees to prevent safety accidents.
1 1 monthly required work contents
1 1. 1 Conduct on-the-job training and safety training for personnel in each position every month according to the training plan, and form training and assessment records.
1 1.2 Go to the production workshop at least twice a month between 22: 00 p.m. and 6:00 the next day to check the safety, production, hygiene and personnel, and make detailed records. If it is found that there is any violation of workshop safety production regulations, disobedience to production arrangements and violation of labor discipline, it shall be signed by the responsible person and handled according to the workshop management system.
1 1.3 Review various statements at the end of each month to ensure that the data is reasonable and true.
12 strengthen the management and preventive maintenance of workshop facilities, equipment, tools and spare parts, ensure that employees strictly implement various operating procedures and ensure the normal operation of equipment.
13 assist the manager of equipment engineering management department to do a good job in the use, maintenance and maintenance of workshop equipment, so as to keep the equipment in good working condition, so as not to delay workshop production.
14 pay attention to the quality problems fed back by the quality management department and the problems found by QA monitors every day, and supervise all positions to be rectified in time.
15 according to the new product trial-production plan, reasonably arrange the trial-production personnel and trial-production time, and complete the trial, pilot and mass production of new varieties as well as the subsequent process verification, new product declaration and process verification in the shortest time.
16 supervise the handover between the night shift monitor and the day shift monitor, understand the safety production situation of the night shift, arrange the department work for the day shift monitor, and check whether there are any potential safety hazards. If there is any problem, eliminate it immediately and report it to the production director in time.
17 is responsible for organizing workshop staff to participate in temporary work such as voluntary labor of the company, so that workshop staff can actively participate and complete the task with good quality and quantity.
18 make good preparations for the company's reservation and temporary notice to foreign guests, including hygiene, on-the-job personnel arrangement, venue layout, etc. And be prepared in advance.