Validation Specialist

Company: CYNET SYSTEMS
Location: Princeton
Posted on: May 27, 2023

Job Description:

Job Description:



Pay Range $68hr - $71.50hr

• 
  
• 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.
  
• Review computerized systems validation documents such as:
  
• 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.
  
• 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
  
  Requirements:
  
  
  • 
    
  • 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.
    
  • 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).
    
  • 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.
    
    

Keywords: CYNET SYSTEMS, Trenton , Validation Specialist, Other , Princeton, New Jersey