Validation Specialist

Company: Sunrise Systems Inc
Location: Princeton
Posted on: March 17, 2023

Job Description:

Sunrise System Inc. is currently looking for Validation Specialist in Princeton, NJ with one of our top client. -

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Job Title: -Validation Specialist

Job Id: 23-01636

Location: Princeton, NJ 08543

Duration: 6Months

Position Type: Hourly Basis on W2 only

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Job Description:

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• 3+ years' experience
  
• Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes
  
• Follow SOPs and industry best practices
  
• Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.
  
• Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system
  
• Review validation deliverables for projects which are contracted to third party suppliers
  
• Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues
  
• Assist in planning, implementing, and documenting user acceptance testing
  
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  -Review computerized systems validation documents such as:
  
  
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  • Requirements Specification
    
  • Design Specification
    
  • CSV Risk Assessment
    
  • Test Plans
    
  • Test Summary Reports
    
  • Data Migration Plan
    
  • Pre/Post Executed Test Scripts
    
  • Traceability Matrix
    
  • Release to Production Statements
    
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    Responsibilities:
    
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    • Direct and review testing
      
    • Provide guidance on quality issues that affect the integrity of the data or the system
      
    • Obtain and respond to QA review
      
    • Participate in establishing standard quality and validation practices
      
    • Independently assess compliance practices and recommend corrective actions
      
    • Approve validated computer system related change requests
      
    • Monitor regulatory and inspection trends and advise the business on suitable action
      
    • Ability to create documents to an existing document standard.
      
    • Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.
      
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      Experience/ Education:
      
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      • Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
        
      • Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. Client ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc)
        
      • Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
        
      • Once trained, have the ability to work independently on CSV projects with minimal oversight.
        
      • Ability to perform in a highly matrixed organization structure
        
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        Skills: - -
        
        
        
        
        Name
        Required
        Experience
        
        
        CSV
        Yes
        3-5 yrs
        
        
        
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        Contact -
        
        Nethravathi H
        
        Direct:732 272 0316- Email: -Nethravathi.H@sunrisesys.com
        
        Or
        
        Satya - -Delivery Manager
        
        Direct: (732) 2720262 -Email:

Keywords: Sunrise Systems Inc, Trenton , Validation Specialist, Other , Princeton, New Jersey