Technician Bulk Manufacturing
15000 人民币~20000 人民币/每月
全职
3~5年
刷新于 4 天前
257 查看
48 申请
上海
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职位职责
Carry out production operations such as weighing materials, preparing powder mixtures and automated line management in capsule or tablet activities according to his/her training curriculum and according to the current procedures of the quality system.
Provide technical support to operators in production activities.
Master the ERP tool (MES) in the management of batch files and associated consumption.
Master and clean equipment, equipment and rooms related to the various stages of production.
Perform format changeovers and production line vacuum.
Update and create technical documents necessary for the operation of the equipment and the line (instructions for use, cleaning).
Comply with the guidelines and instructions set out in the quality system of our pharmaceutical site.
Ensure the realization of the production operations of industrial batches in a GMP environment and work independently and efficiently according to the instructions of his manager.
Control, record and complete pre-established working documents to ensure a follow-up of the operations carried out (batch files filled according to GMP / GMP).
Perform basic physical checks of manufactured products.
Participate in and support the validation of industrial processes and the manufacture of validation batches.
Comply with production objectives, in particular compliance with the established schedule.
Generate maintenance service requests in the event of equipment failure and follow up until production resumes.
Analyze equipment failures and support maintenance in the event of an intervention.
Open deviations in the quality computer system.
Perform the format changes and basic settings defined in the procedures.
Be a technical referent for operators.
Train new employees and operators on the various production lines and be the training referent (On the Job Qualified Trainer).
Comply with the safety and security rules of the pharmaceutical site.
Announce dangerous situations, near-misses/incidents and accidents that may occur on the site to your direct manager and to the EHS department.
职位要求
Experience / Education
Have an initial training at CFC level and 5 years' experience in pharmaceutical production or ideally 3 years as a technician in the pharmaceutical industry.
Knowledge / Skills / Abilities:
Have a thorough knowledge of the GMP / GMP environment, and have a good knowledge of the pharmaceutical industry, especially in the sector of mixtures and powder encapsulation and/or compression
Have a perfect command of French and notions of English (A2).
Be organized and rigorous, and have great interpersonal skills for teamwork.
Communicate clearly with support services
Have a critical mind and is a force of proposal with a view to continuous improvement.
Have knowledge of computer tools (Word, Excel) and an MES.
Share knowledge and train new employees and operators on the various equipment in the bulk area.
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