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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