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职位详情
岗位职责
Responsible for the check in line clearance of production, material status, reprocessing, and packaging stages and other critical steps or aspects which may influence the quality of products.
负责检查生产清场、物料状态、返工、包装和其他可能影响产品质量的步骤;
Responsible for shop floor quality monitoring, sampling and relevant works, make sure all the products produced in Zhongshan site compliance with GMP.
负责现场质量监控、取样和相关工作,确保所有中山工厂生产的产品符合GMP要求;
Responsible for the checking and qualifying of the equipment maintain, process and materials change.
负责检查和确认设备维修、工艺和物料的变更情况收集;
Responsible for the environmental monitoring and water system monitoring.
负责环境监控和水系统监控;
Responsible for checking on the disposal materials and monitor the destroying operation.
负责不合格物料的检查和监控销毁;
Participate in any quality related issue investigation and evaluation.
参与质量相关事件的调查和评估;
BPR collecting and first review.
批记录的收集整理和初审。
任职要求
Education教育 : Graduate from pharmacy or relevant specialties above junior college.
必须是药学或相关专业大专以上的学历;
Languages语言: Mastering certain computer operating and professional English, and could finish task satisfactorily which refer to them.
具有一定的电脑操作水平和专业英语水平,能很好的完成工作中涉及的这两方面的工作。
Experience经验: Obtained proper training on pharmaceutical quality management, and with more than one year’s relevant working experience.
有较好的药品质量管理培训和一年以上相关工作经验;
Familiar with items of GMP, can comply with requirements of GMP and relevant SOP strictly, and could judge and handle correctly common questions.
熟悉GMP条款,并能严格的遵守GMP要求和执行相关的SOP,对药品生产和质量管理中的一般问题能够做出正确的判断和处理;
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