Validation Specialist

3 days ago


Princeton, New Jersey, United States Futran Tech Solutions Pvt. Ltd. Full time

Job Title: Validation Specialist

Job Summary: We are seeking a highly skilled Validation Specialist to join our team at Futran Tech Solutions Pvt. Ltd. The ideal candidate will have a strong background in computer system validation, regulatory compliance, and quality assurance.

Key Responsibilities:

  • 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 apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues

Requirements:

  • 4+ years' experience in computer system validation and regulatory compliance
  • Advanced knowledge of MS Office suite and Visio
  • Experience with electronic document management systems, application development and lifecycle management, and IT service management systems
  • Excellent oral and written communication skills in English
  • Ability to work independently on CSV projects with minimal oversight

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