Description

Manage computer system validation (CSV) projects and ensure compliance with regulatory standards.

Responsibilities

• Develop and maintain CSV policies, procedures, and documentation in alignment with FDA, EMA, GxP, and GAMP standards.
• Lead CSV project execution, including risk assessments, validation planning, requirements gathering, testing, and reporting.
• Conduct validation assessments and gap analyses to identify risks and develop remediation plans for new or existing systems.
• Review and approve validation documentation such as protocols, test scripts, traceability matrices, and validation reports.
• Collaborate with IT, quality assurance, and regulatory affairs to ensure systems meet functional specifications and compliance standards.

Required Skills

• 5+ years of experience in computer system validation.
• Deep understanding of GxP regulatory requirements.
• Experience with EMA regulations.
• Proficiency in CSV methodologies and documentation.
• Ability to conduct formal risk assessments and gap analyses.
• Experience managing validation lifecycles for software applications.
• Knowledge of data integrity and electronic records management.

Preferred Skills

• Degree from any graduate program.

Key Skills

Education

ANY GRADUATE