Validation Specialist

4 weeks ago


Princeton, New Jersey, United States Futran Tech Solutions Pvt. Ltd. Full time
Job Title: Validation Specialist

At Futran Tech Solutions Pvt. Ltd., we are seeking a highly skilled Validation Specialist to join our team. The ideal candidate will have a strong background in computer system validation and a proven track record of ensuring compliance with regulatory requirements.

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 to ensure the highest level of quality and compliance.
  • 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.
  • Assist in planning, implementing, and documenting user acceptance testing.
Requirements:
  • 4+ years' experience in computer system validation.
  • Advanced knowledge of complete MS Office suite and Visio.
  • Firm understanding of technology platforms as needed for project.
  • Experience with electronic document management systems, application development and lifecycle management, and IT service management systems.
  • Excellent oral and written communication skills in English.
  • Strong expertise and ability to interview and accurately interpret communication requirements of team members.
  • Ability to work independently on CSV projects with minimal oversight.
  • Ability to perform in a highly matrixed organization structure.
  • Bachelor's degree preferred or equivalent experience.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for computer system validation, we encourage you to apply for this exciting opportunity.


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