1、Manage the Validation program for the project, including planning, training, metrics, priorities, resources, etc.
管理项目的验证程序，包括计划、培训、度量指标、优先顺序、资源等。
2、Fully responsible for the compliance of the project validation process, from the inputs ( KPIV, KPOV, FMEA, sampling plan, …) to the deliverables ( validation report, .. ). First point of contact during Customer or notified body audits for all the subjects related to validation compliance.
全面负责该项目验证过程的合规性，从输入（KPIV、KPOV、FMEA、抽样计划……）到交付（验证报告……）。在客户或公告机构审核中负责首先应对所有相关的验证符合性事项。
3、Improve the overall validation process ( cycle time, deviation, …).
改善整体的验证过程（验证周期、偏离……）。
4、Reviewing and approving all protocols and reports to ensure compliance to the Validation Master Plan, the Validation Procedure and the BDX Validation Toolkit.
审查和批准项目所有的验证方案和报告，以确保其符合验证主计划、验证程序和BDX验证工具包。
 Performs statistical analysis using tools such as: de****ive statistics, measurement system analysis, hypothesis testing, designed experimentation, control chart theory, acceptance sampling, etc.
运行以下工具进行统计分析：如描述性统计、测量系统的分析、假设检验、设计实验，控制理论图、验收抽样等。
5、Participate on the world wide validation team for DS,BDRD.
代表DS,BDRD参与全球验证团队。
6、Participate in the change control committee and bring its expertise during the ****uation of the proposed change
参与变更控制委员会，为拟议变更的评估过程提供专业意见。
7、Be familiar with plant, divisional and worldwide goals related to quality, validation, risk management and change control.
熟悉工厂、区域和全球的涉及到质量、验证、风险管理和变更控制的目标。
8、Other duties as assigned.
其他分配的职责。
Others其它
9、Performs any other task(s) as assigned, or defined in related quality procedure.
执行任何其他任务）为分配的，或相关质量程序规定。
(All required authority will be issued to implement responsibility listed above automatically after the approval of this Job De****ion.)
（本职位描述批准后，所有相应的权限将自动生效以履行上述职责。）

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