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  • Workshop Director (New Preparation Project)

    HR management

    Regular college

    1

    2021-10-05

    Job Responsibilities: 1. Responsible for the installation, commissioning and verification of production equipment in the preparation workshop, complete the selection of production equipment, drafting of URS, and implement FAT, SAT, IQ, OQ and PQ; 2.Complete the formulation of the document system related to the production of general preparation workshops in the GMP system, process regulations, risk assessment, post operation SOP, and production equipment operation SOP; 3. Complete the pilot batch, engineering batch, PPQ, aseptic process simulation experiment, product process verification, cleaning verification and trial production in the general preparation workshop. Qualifications: 1. Bachelor degree or above in pharmacy, pharmacy or related majors; 2. More than 5 years of experience in chemical pharmaceutical production or process technology development, and more than 3 years of experience as a workshop director or production supervisor; 3. Familiar with the related production, process and operation process of lyophilized powder injection, vial injection, pre-filled injection and other preparations; 4. Familiar with the use of process equipment and facilities in the workshop and conduct daily management of it; 5. Can independently lead the team to solve technical problems and deviation investigations during the production process; 6. Familiar with the quality management standards of pharmaceutical production and GMP site management and document preparation; 7, Familiar with the specific requirements of workshop verification, can lead the team to complete the process verification, cleaning verification, equipment verification and other work in the workshop; 8. Have good organization and coordination, teamwork awareness and leadership management capabilities.
  • Filling (preparation of new items)

    HR management

    Regular college

    1

    2021-10-05

    Job Responsibilities: 1. Participate in equipment installation, commissioning and verification during plant interior construction, assist workshop director to complete production equipment selection, URS drafting, implement FAT, SAT, IQ, OQ and PQ, mainly including isolator, filling line, freezing Dryer, rubber plug aluminum cover cleaning machine, light inspection packaging equipment, etc .; 2. Assist the workshop director to complete the production-related document system in the GMP system, filling process regulations, risk assessment, post operation SOP and production equipment operation SOP; 3. Assist the workshop director to complete the pilot test, engineering batch, PPQ, medium simulation and filling test, product process verification, cleaning verification and trial production. Qualifications: 1. College degree or above in pharmacy, pharmacy or related majors; 2. More than 3 years of production experience in small-volume injections or freeze-dried powder injections, and more than 1 year of job experience as head of the filling workshop or production supervisor; 3. Familiar with the related production, technology, and operation procedures of preparations such as lyophilized powder injection, vials, prefilled injections, etc .; proficient in the operation of aseptic preparations (bottle washing, filling, freeze drying, capping, etc.) 4. Familiar with the use of process equipment and facilities in the filling workshop and conduct daily management of it; 5. Can independently solve technical problems and deviation investigations during the filling process; can design and optimize the filling process; 6. Familiar with the quality management standards of pharmaceutical production and GMP on-site management and document preparation; 7. Familiar with workshop verification, can complete process verification, cleaning verification, equipment verification, etc. in the filling workshop; 8. Have good learning ability and stress resistance.
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Borui Medicine

address:

Building C25-28, 218 Xinghu Road, Suzhou Industrial Park, Jiangsu Province, China

Borui Medicine

phone:

0512-62620988

 

Borui Medicine

Fax:
0512-62551799

Copyright: Brilliant Biomedical (Suzhou) Co., Ltd. Website: CE Dongli · Suzhou Su ICP No. 18,000,014           

Copyright: Borui Biomedical (Suzhou) Co., Ltd. 

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