工作范围 Scope 本岗位工作偏重于“产品技术、过程技术、系统技术”中的新产品、过程难点、过程 改进和系统符合等工作,工作范围包含仪器生产的技术支持活动,新产品引进的项 目管理,与新产品符合相关的技术转移和产品上市活动,以及系统化的项目改进和 解决方法等。 生产技术支持(产品工艺流程设计,过程难点解决等) 产品技术符合(产品批量试验、产品技术资料起草等)。 过程技术符合(验证)活动(如产品验证、过程验证、设备和性能验证等) 系统技术符合(改进)活动(如LSS 或CPI 项目、系统软件和应用等) 主要职责 Principal Responsibilities 负责仪器生产的技术支持工作,按计划完成技术文件编制及图纸设计等。 协助研发进行产品的工艺流程设计,协助进行产品的模拟试验及测试等。 仪器生产的技术(文件)管理和各种相关的技术问题的调查。 仪器生产的流程优化设计,维护仪器生产的完整的DMR 文件。 起草和更新原材料标准及原材料检验程序和方法,参与评估供应商的能力。 参与各种包装材料和标准件的供应商认证,并提供(验证)技术支持。 年度验证主计划的跟踪和实施,包含各种再验证方案的起草和实施 工艺验证的实施,熟悉产品和过程工艺特征、特点和工艺技术要求。
Function: MA Reports to: Solution Manager Job Position: OP&Service Solution Specialist Local Title: Service and Original Parts Specialist Budget size: # of direct reports/# of indirect reports 0 Location: Mutiple Domestic (D), Regional (R) or Global (G):
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