Job Responsibilities Regulatory Intelligence & Advisory Monitor technology regulatory and legislative developments across NFRA, PBOC, SAFE, CAC, CBA, CFETS, and SGE. Support China LIB Compliance on technology regulatory and compliance matters. Own and coordinate RFI responses
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。
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