Apply

Validation Specialist

Job Post Index 22538A-Sy##
Location Princeton, NJ
Description: Description
  • 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
  • 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 appraised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues
  • Assist in planning, implementing, and documenting user acceptance testing
  • 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
  • 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
Skills: Qualifications
  • 6+ years’ experience
  • 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.
  • Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.
  • 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. HP 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
  • Must Haves:
    • 3 years experience in Computer System Validation
    • 3 years of ALM
    • 3 years of CSV Documentation author and review, approve
    • 1-2 years of experience in Change Control
    • Should be able to work with minimal supervision
  • Desired:
    • Experience/understanding of Data Integrity concepts
    • Understanding of GAMP categories and validation approaches

Apply For This Job

  • Accepted file types: docx, doc, pdf, pages, txt.
WHY SYNECTICS?
LOOKING FOR A JOB?
LOOKING FOR TALENT?