Validation Specialist

7 hours ago

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

Futran Tech Solutions Pvt. Ltd. is seeking a highly skilled Validation Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring that our computer systems meet the highest standards of regulatory compliance.

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
  • Assist in planning, implementing, and documenting user acceptance testing
  • 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, and Release to Production Statements
  • 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
Requirements:
  • 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 perform in a highly matrixed organization structure
  • Bachelor's degree preferred or equivalent experience

Futran Tech Solutions Pvt. Ltd. offers a dynamic and challenging work environment with opportunities for growth and development. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.

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