GENERAL FUNCTION

基本职能

• As the Site Validation Leader, the position is responsible for execution and implementation of effective validation of all processes and equipment of the site BDRD Suzhou according to cGMP and Corporate requirements. It includes developing and maintaining the Validation Master Plan, developing a validation support structure, and training and educating associates.

  作为工厂验证负责人，负责根据cGMP和集团要求执行和开展碧迪快速诊断工厂（苏州二厂）内所有过程和设备的有效验证活动。它包括制定和维护验证主计划，发展验证的支持机构，以及培训和教育员工。

JOB RESPONSIBILITIES

工作职责

• Manage the Validation program for the site, including planning, training, metrics, priorities, resources, etc. Ensure timely validation task implementation.

  管理工厂的验证程序，包括计划、培训、度量指标、优先顺序、资源等，确保及时完成验证任务。

• Responsible for SVMP establishment and implementation, including equipment validation, facility validation, process validation and software validation if any.

  负责工厂验证主计划的制定和执行，包括设备确认、厂房确认、过程验证和软件验证。

• Fully responsible for the compliance of the site 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.

  全面负责该工厂验证过程的合规性，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。

• Reviewing and approving all protocols and reports to ensure compliance to the Validation Master Plan, the Validation Procedure and the BDX Validation Toolkit. Review and approve validation deviation/discrepancy as required.

  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。按要求审核和批准验证偏差。

• Performs statistical analysis using tools such as: descriptive 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。

  
  

• As a Change Control Coordinator, organize and communicate for change control Review Board (CCRB), manage change documents and notification, monitor change controls. Participate in the change control committee and bring its expertise during the evaluation of the proposed change. Be engaged with design control process to develop process validation strategy.

  作为变更协调员，为变更控制委员会组织和沟通，管理变更文档和通告，监控变更控制。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。参与设计控制过程，制定过程验证策略。

• Establish and maintain calibration program with compliance to related regulation and equipment/instrument user requirement.

  负责执行和维护校验规程，确保符合相关法规要求和设备/仪器要求。

• Participate on the PS &DS world wide validation team for BDRD Suzhou.

  代表苏州工厂参与PS &DS全球验证团队。

• Participate in risk management activities.

  参与风险管理活动。

• 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。

• Ability to become a BD certified validation practitioner and BD certified validation trainer.

  有能力成为BD认证验证从业者和BD认证验证培训师。

• Responsible for site wide validation training.

  负责工厂范围的验证培训。

• Support Quality Assurance routine activities.

  支持质量保证日常活动。

  
  

  Others其它

• Performs any other task(s) as assigned, or defined in related quality procedure.

  完成其他指定工作，或相关质量程序中定义的工作。

  
  

  (All required authority will be issued to implement responsibility listed above automatically after the approval of this Job Description.)

  （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。）

  
  

  JOB REQUIREMENTS

  职位要求

  
  

  Education 教育

• Bachelor degree or above

  本科或以上学历

• Bio-science or medicine related is a plus

  生命科学或医药相关学历优先

  
  

  Experience 工作经验

• Atleast 8 years Validation Experience medical device, pharmaceutical, or food related industry.

  具有至少8年医疗器械、制药或相关食品行业验证工作经验

Skill / Knowledge / Abilities 技能/知识/能力

• Effective communication skills/ Fluent in English

  有效沟通交流技能/流利的英语

  
  

• Project Management skills

  项目管理技能

• Knowledge of Lean and Six Sigma for Manufacturing

  精益生产和六西格玛知识

• Training and education skills

  培训和教育技能

• Knowledge of analytical and statistical tools

  分析和统计工具知识

• Knowledge of site processes

  工厂过程知识

• Set priorities among multiple tasks

  多重任务优先管理

• Demonstrate effective leadership

执行有效管理

Interaction交叉关系

• Internal customer (Quality Control etc.)

  [drivers:- risk management, product quality, change control, audit, compliant, etc.]

  内部客户（质量控制等）

  [ 驱动：风险管理、产品质量、变更控制、审核、投诉等]

• Inter-department (Materials, Manufacturing, Engineering, Product Support etc.)

  [drivers:- equipment performance, product quality, changes, process, etc.]

  交叉部门（物料部，生产部，工程部，产品支持部）

  [ 驱动：设备性能、产品质量、变更、过程等]

  
  

  Supervision and Reporting Relationship管理和汇报关系

• Reports directly to Quality Manager.

  直接汇报质量经理

Working Conditions工作环境 / Conditions环境 / Physical Requirements环境要求

• Manufacturing office environment.

生产办公环境

• Willing to do oversea travel

  适应海外出差

  
  

上班地址：苏州工业园区出口加工区B区瑞浦路9号

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to better diagnose disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit bd.com.

关于BD

BD是一家全球化的医疗技术公司，通过改善医学发现方法、医疗诊断效果和护理质量以引领世界健康。BD关注并支持每位一线医务工作者，致力于通过研发创新技术、服务和解决方案，帮助患者改善临床治疗，并帮助医护人员改进临床流程。BD及其65,000名全球员工秉承高度的热情和信念，致力于帮助提升患者的治疗效果，为临床医护人员提供安全、高效的护理给药流程，协助实验室科学家们更有效地诊断疾病，并提升科研人员研发新一代诊断及治疗疾病的能力。BD在几乎所有国家均设有分支机构，与全球范围内的组织机构积极合作，携手应对最具挑战的全球健康问题。通过与客户的紧密协作，BD以改善治疗结果，降低医疗成本，提升诊断效率为己任，帮助加强患者和医护人员的安全并扩大医疗可及性。2017年，BD欢迎巴德及其产品加入BD大家庭。更多信息，敬请访问www.bd.com/china。