2 In accordance with the issued production plan, reasonable arrangements for the workshop staffing of various positions and the production of the preparatory work, in strict accordance with the process requirements for production, the ability to solve problems, remove production constraints, to ensure the continuous operation of the production, the completion of the production tasks, the quality of the products produced by the product quality, production, yield, and is responsible for the yield.
3 according to the production plan to co-ordinate the workshop daily production and personnel, so that each position coordinated production, to prevent the waste of personnel, equipment, materials, time due to mismanagement, in order to ensure that the yield (yield), the quality of the premise, have the responsibility to reduce the cost of production.
4 according to the production task of the number of heavy, flexible adjustment of the production quota and the configuration of the staff of all positions, so that the staff of all positions to maximize the potential of full load production, while reflecting the principle of more work, more pay.
5 Responsible for the training of employees to ensure targeted, timely and effective.
5.1 Pre-job training for newly arrived employees. Including the company's rules and regulations, job responsibilities, work system, safety knowledge and related equipment operation. Do a combination of theory and practice. After passing the test, new employees can be on duty.
5.2 In accordance with the monthly training program for all employees of the workshop training assessment.
6 Responsible for the quality management of the workshop personnel, and do a good job of staff thinking.
6.1 Understand the ideological dynamics of the staff, the workshop staff education and training. Publicity of the company's policies, in-depth implementation of the company's systems to stabilize people's minds, unity, to ensure safe and civilized production.
6.2 often exchange ideas with the staff, to understand the staff's work attitude and state of life, and timely resolution of the problems reflected by the staff, if outside the scope of competence of the problem, should be reported to the competent leadership in a timely manner, after the resolution of timely notification of the staff, can not be ignored, delayed or perfunctory.
6.3 Adoption of staff rationalization proposals to stimulate the enthusiasm of staff work.
6.4 educate employees not to do things detrimental to the workshop, the company's honor, interests.
7 Responsible for the workshop GMP certification inspection and other inspections at all levels of hardware and software work:
7.1 Before the inspection, the organization of personnel on the software, hardware, self-inspection, self-inspection of the problems found in a timely manner to organize the rectification, check the results of the implementation of rectification. Found that there are problems that can not be solved timely report to the person in charge of production.
7.2 In the inspection, accompanied by inspectors, do a good job of software, hardware inspection preparation and explanation, if there is a problem that can not be clarified or inspectors have questioned the problem immediately to the person in charge of production or quality of the person in charge of the report to ensure that timely problem solving.
7.3 After the inspection, according to the problems raised by the inspectors, organize the personnel to carry out rectification, draft rectification reports and check the results of the implementation of rectification.
8Familiarize with GMP provisions, review various GMP documents and records.
8.1 Responsible for organizing the preparation, revision, issuance and supervision of the implementation of various documents in the workshop (including personnel duties, process procedures, job operation SOPs, cleaning SOPs, verification and validation, production master records, and auxiliary records), to ensure that the contents of the documents are consistent with the production and are operable.
8.2 Responsible for reviewing the batch packaging instructions and limit of material orders prepared by the workshop technician, and signing and issuing them after reviewing and approving them.
8.3 Responsible for auditing the batch production records submitted after the workshop software clerk collated, signed on the production records after the audit is correct, and then submitted to the quality management department.
8.4 Ensure that the records are filed accurately and in a timely manner before the seventh day of the month, and can not be filed with a description of the situation explaining the reasons.
9 Daily mandatory work content
9.1 At least once a day on the inside and outside of the workshop to check, starting from the workshop under the jurisdiction of the share of the area tour, checking the staff, health, plant, facilities, equipment, water, electricity, gas, found that the problem is resolved in a timely manner.
9.1.1 Check the production site safety of each post, process implementation, product quality, GMP implementation, personnel operation, post hygiene, and hygiene of the sharing area.
9.1.2 Check whether the employees comply with the factory rules and regulations, operating procedures, the workshop of the various production progress.
9.1.3 Responsible for solving the problems of production constraints in all aspects of production, found that the day of the problem to deal with, unable to deal with the problem, the day of the timely report to the manager of the production management department or the person in charge of production, and with the leadership of the study to determine the solution and the implementation of the implementation.
9.2 daily to the production manager to report the workshop production completed hu hu gaosu princely hinge arbuckle supply busy situation as well as the abnormal situation, to the leadership to indicate the next stage of production arrangements and production tasks.
9.3 Review the daily production reports to ensure that the data is true and accurate.
10 weekly work must be done: the organization of a workshop meeting, the meeting includes:
10.1 Summary of last week's production, completion, problems.
10.2 Lay out the next week's production tasks, and staff to discuss how to improve product quality, to ensure the yield.
10.3 Train employees on record filling, equipment operation, cleaning and sanitation, and other systems.
10.4 Implement the spirit of the company's meetings, emphasize the importance of production safety, and provide safety training to employees to prevent safety accidents.
11 Monthly mandatory work content
11.1 Monthly job training, safety training for each position in accordance with the training program, and the formation of training and assessment records.
11.2 At least 2 times a month between 22:00 pm - the next day 6:00 pm to the production workshop to check the safety, production, health, personnel, etc. and make a detailed record, such as found in violation of the workshop safety and production regulations, disobedience to the production arrangements and violation of labor discipline, signed by the person responsible for dealing with in accordance with the workshop management system.
11.3 Review various reports at the end of each month to ensure that the data is reasonable and true.
12 Strengthen the workshop facilities, equipment, tools, spare parts management and preventive maintenance and maintenance, to ensure that employees strictly implement the operating procedures to ensure the normal operation of equipment.
13 assist the manager of the equipment engineering management department to do a good job in the use of workshop equipment, maintenance, maintenance work, so that the equipment can maintain a good state of operation, so as not to delay the workshop production.
14Emphasis on the quality of feedback from the quality management department and the QA monitors found every day, supervise the positions in a timely manner to rectify and implement in place.
15In accordance with the new product trial production plan, reasonable arrangement of trial production personnel and trial production time, in the shortest possible time to complete the new varieties of small pilot, pilot, large-scale production work and subsequent process verification, new product declaration, process verification work.
16Supervise the handover between night shift and day shift supervisor, understand the safety production situation of the night shift, arrange the day's work to the day shift supervisor, check whether there is any hidden danger, if there is any problem, remove it immediately, and report to the person in charge of the production if it can't be solved in time.
17 is responsible for organizing the workshop staff to participate in the company's various voluntary work and other temporary work, so that the workshop staff can actively participate and quality and quantity to complete the task.
18 Do a good job in advance to prepare for the company's scheduled and temporary notification of foreign personnel to visit the preparatory work, including hygiene, in-service personnel arrangements, site layout and so on.