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Computer System Validation Expert

3 weeks ago

Jersey City, New Jersey, United States Hays Recruitment Full time
Role Description

The Validation Specialist plays a critical role in ensuring the accuracy and reliability of our computerized systems. Your primary responsibilities will include reviewing computerized systems validation documents, directing and reviewing testing, and providing guidance on quality issues that affect the integrity of the data or the system.

About the Position

This is a contract/temporary role that offers a unique opportunity to gain valuable experience in a highly matrixed organization structure. You'll work closely with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues. In return, you'll receive comprehensive training and support to help you succeed in this challenging role.

Responsibilities

• 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

To be successful in this role, you'll need 6+ years of experience applying FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes. You should follow SOPs and industry best practices, possess expertise on Good Documentation and Good Testing Practices, and facilitate the Computer system Validation Risk Assessment. You'll also review validation deliverables for projects contracted to third-party suppliers and maintain close communication with stakeholders and team members.

What We Offer

This position offers a contract/temporary role with the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K, and Life Insurance ($20,000 benefit). You'll work with a professional recruiter who has intimate knowledge of the industry and market trends, ensuring a smooth and efficient hiring process.