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Role: Validation Specialist
Location: New Brunswick or Lawrenceville, NJ – Day 1 Onsite
Contract: 12+ Months

Job Description:

• 6+ years of experience in applying 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 in Good Documentation and Good Testing Practices to train business users who are less familiar.
• Facilitate Computer System Validation Risk Assessments to identify governing regulations and validation deliverables during system development.
• Review validation deliverables for projects contracted to third-party suppliers.
• Maintain close communication with stakeholders and team members regarding computerized system needs, validation impacts, project status, and other relevant issues.
• Assist in planning, implementing, and documenting user acceptance testing.

Roles & Responsibilities:

• Review computerized system validation documents, including:

• • 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 activities.
• Provide guidance on quality issues affecting data integrity or the system.
• Obtain and respond to QA reviews.
• 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 appropriate actions.
• Create documents adhering to existing document standards.
• Develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.
• Demonstrate advanced knowledge of MS Office Suite and Visio.
• Possess a firm understanding of relevant technology platforms for projects.
• Experience with electronic document management systems (e.g., Documentum, Qumas, SharePoint).
• Familiarity with application development and lifecycle management tools (e.g., HP ALM, JIRA).
• Experience with IT service management systems (e.g., ServiceNow, SAP Solution Manager).
• Excellent oral and written communication skills in English.
• Strong expertise in conducting interviews and accurately interpreting communication requirements.
• Ability to work independently on CSV projects with minimal oversight once trained.
• Capable of performing effectively in a highly matrixed organization structure.

“In case I missed your call, Email is the best way to reach me ”

Thanks & Regards

Niteesh

Technical Recruiter

Phone: +1 6144945423

Email: [email protected]