QAWork Place: Suzhou Changshu
1. Under the leadership of the QA manager, carry out various quality management work
2. Responsible for dynamic inspection of the production site to ensure that all key quality control points throughout the production process are under monitoring;
3. Responsible for drafting and revising quality system documents related to the scope of supervision;
4. Assist in the investigation and handling of related deviations, complaints and other activities;
5. Participate in GMP self-inspection activities, implement corrective measures and supervise their implementation;
6. Supervise and inspect whether the standard substances, reference substances, reagents and test solutions are stored, used, stored and distributed as required, and assist and urge the workshop to solve the actual GMP problems;
7. Irregular GMP inspection and annual self-inspection of the department;
8. Do a good job monthly analysis report as required, and report to the department head in a timely manner;
9. Have a high ideological quality and a strong sense of work responsibility, constantly learn business knowledge and improve work ability;
10. Complete other tasks assigned by superiors.
1. College graduates or above in pharmacy, chemistry, biology, analysis and other related majors;
2. Solid pharmaceutical knowledge, familiar with the basic knowledge of GMP;
3. Be serious and meticulous in doing things, be proactive, and be steady and down-to-earth;
4. Familiar with GMP related regulations.
QC AnalystWork Place: Suzhou Changshu
1. Responsible for the company's accessories, packaging materials, finished products, etc.Instrumental Analysis, Physical Chemistry, MicrobiologyIndicator test.
2. In the inspection work, strictly implement various inspection management regulations, product quality standards and inspection operation regulations, and carefully fill in the inspection records and auxiliary materials.
3. Participate in the compilation and revision of quality standards and inspection procedures.
4. Responsible for cleaning and maintenance of inspection equipment.
1. Able to use various office software proficiently, such as word, excel, ppt, etc., and can use Excel for data processing;
2. Have a certain English foundation, CET level 4 or above, and be able to use English software proficiently;
3. Get the experimental method, be able to independently complete the experiment (pretreatment of samples, preparation of solutions, etc.) and report the results;
4. Proficient in liquid chromatography, gas chromatography and data analysis;
5. Basically be able to independently complete the drafting of the verification scheme of the analytical methodology and the collation of the verification report;
6. Positive working attitude, serious, good at thinking about problems; experimental ideas are clear and clear;
7. Have a certain basic analytical chemistry experiment; in the instrument position, can operate the liquid chromatograph independently, and the working experience of the gas chromatograph is preferred
Major: pharmacy, chemistry, biology, pharmacy, analysis, pharmaceutical preparation related majors
R&D experimenterWork Place: Suzhou Changshu
1. Strictly follow the relevant test subjects and test plans to do various research and development tests, and fill in the test records and test reports in a timely manner.
2. responsible for all kinds of data issued by the test;
3. Take care of the test equipment, maintain regular maintenance and keep it properly, to ensure that the test equipment is in good condition and the value is accurate;
4. After the test, clean up the site, arrange and place the test equipment and test data, maintain a clean and civilized working environment, and be clean, hygienic and reliable;
5. Assist in other matters authorized by the superior, and complete the temporary work tasks assigned by the leader in a timely manner.
1. Outstanding graduates with bachelor degree or above in pharmacy, chemistry and biology related majors;
2. Solid knowledge of organic chemistry;
3. Have experience in organic synthesis experiments;
4. Work conscientiously and meticulously, be proactive, be steady and down-to-earth; have good safety awareness and good teamwork spirit.
5. Once hired, the treatment will be favorable.
Formulation workshop director / SupervisorWork Place: Suzhou Changshu
1. Fully responsible for the daily production of the preparation workshop, organize and implement production according to production instructions, and complete production tasks with quality and quantity;
2. According to the production instructions, before production, check the batch number and inventory of the corresponding raw and auxiliary materials, packaging materials, and supervise the process of material procurement, inspection, and release;
3. Responsible for the whole process of drug production and quality management, assist the Quality Assurance Department to do a good job in product quality inspection;
4. Make a correct judgment and properly handle the problems that occur on the production site in a timely manner;
5. Responsible for the process technology management of the workshop, do a good job in the supervision of process control points and production deviations; be responsible for organizing the continuous optimization of production processes and processes to ensure continuous improvement of efficiency；
6. Organize workshop personnel to analyze various problems and deviations or assist the quality department to carry out deviation investigation and cause analysis, and formulate effective corrective and preventive measures;
7. Organize workshop personnel to complete the daily cleaning and maintenance of the production area and equipment in the production area as required;
8. Strictly abide by the company's management system, obey work assignments, and abide by labor discipline.
9. Responsible for necessary on-the-job training and continuing training for workshop production related personnel;
10. Responsible for organizing the team building of the department in charge, formulating employee training plans, and ensuring the continuous optimization of the talent echelon; organizing the preparation of the department's annual training plan, and regularly monitoring the implementation progress of the training plan.
11. Complete the regular performance appraisal of the employees of the department as required;
12. Participate in GMP self-inspection and implement rectification to ensure compliance with regulations of the production organization. 13. Continue to optimize and improve GMP, EHS and other system construction, ensure safe production management, and ensure the smooth passing of various audit certifications; participate in verification programs , the formulation and implementation of the re-validation plan;
13. Cooperate with other departments to complete other tasks assigned by superior leaders.
1. College degree or above, major in pharmacy, pharmaceutical engineering, chemistry, etc.;
2. Have 5 years and above experience in the management of production workshops of pharmaceutical companies, and experience in the management of oral solid preparation workshops and gel workshops is preferred;
3. Have their own management concepts and practical experience in team management and talent echelon construction;
4. Serious and responsible work, strong communication skills and sense of cooperation, and strong ability to withstand pressure.
5. Once hired, the treatment will be favorable
Production technicianWork Place: Suzhou Changshu
1. Under the leadership of the production manager, carry out various production technical work
2. Assist the production manager to prepare documents such as product process regulations, post operation methods, etc.
3. Responsible for on-site spot checks on the production progress of the workshop and various production records, summarizing and reviewing the production batch records
4. Entering the production workshop, familiar with the production process and process
5. Cooperate with R&D and production for technical handover
6. Complete other tasks assigned by superiors
1. College graduates or above in pharmacy, chemistry, biology, pharmacy, analysis, chemical machinery, mechanical equipment and other related majors；
2. Professional basissolid knowledge；
3. Work carefully and meticulously, be proactive, be steady and down-to-earth; have good safety awareness and good teamwork spirit。
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