Analyst, IT Validation

Company: Katalyst Healthcares & Life Sciences
Location: South Plainfield
Posted on: May 28, 2023

Job Description:

Responsibilities :

• 
  
• Validation Services and Technical Writing
  
• Creation, review, approval, and processing of Computer System Lifecycle deliverables including:
  
• User Requirements, Specifications, Test Plans, and IQ, OQ or PQ Test Scripts
  
• Implementation of the most appropriate validation methodology for the Business effort.
  
• Fostering of effective relationships with IT customers to better understand processes and requirements and attaining the most beneficial computer system solutions that meet all relevant regulatory standards.
  
• Active engagement with ISQA to ensure compliance on IT projects and enhancement efforts.
  
  Requirements
  
  
  • 
    
  • BS/Equivalent Training/Certification and minimum of 2 years of relevant experience in computer systems validation, systems development life cycle methodologies and change management.
    
    Necessary Knowledge, Skills, and Abilities
    
    
    • 
      
    • Expertise in computer system validation, Systems Development Life Cycle (SDLC) methodologies.
      
    • Knowledge of computer system regulations, standards, and best practices
      
    • Strong versatility of written and verbal communication skills, including documentation of requirements, technical solutions, and primary validation documentation
      
    • Demonstrate strong technical writing skills and ability to teach others in the application of technical writing principles.
      
    • Technical knowledge of the following computer systems and software (at a minimum):
      
    • Microsoft software packages such as Outlook, Word, Excel, PowerPoint, Explorer, and MS Project
      
    • Veeva Vault
      
    • Document Management Systems /QA Systems.
      
    • Working knowledge of project management principles, and ability and experience to operate under tight timelines, within budget and to specified quality and compliance goals.
      
    • Solid relationship and conflict management skills and ability to navigate complex, fast[1]moving, and constrained business environments in a self-directed manner.
      
    • Strong work ethic, learning and change agility, operates comfortably and effectively in an ambiguous and fast-paced environment.
      

Keywords: Katalyst Healthcares & Life Sciences, New York , Analyst, IT Validation, Professions , South Plainfield, New York