CSV Analyst – Quality Systems

About the role

The CSV Analyst – Quality Systems will support Computer System Validation (CSV) activities for quality‑related computerized systems. Working in Bogota, the analyst ensures compliance with regulatory requirements, internal policies, and quality system standards, helping maintain data integrity and audit readiness.

Key responsibilities

• Support validation lifecycle activities, including planning, risk assessment, testing, documentation, and maintenance.
• Develop and maintain validation documentation such as protocols, reports, and traceability matrices.
• Collaborate with Quality Systems, IT, and business teams to ensure compliant system implementation and change management.
• Perform data integrity assessments and support audit readiness for quality‑related systems.
• Assist in the ongoing monitoring and re‑validation of systems as required.

Required profile

• Experience with computer system validation in a regulated environment.
• Familiarity with quality system standards and regulatory requirements (e.g., FDA, ISO).
• Ability to work closely with cross‑functional teams including Quality, IT, and business stakeholders.

Required skills

What we offer

• Opportunity to contribute to a global healthcare leader during a strategic business separation.
• Access to professional development and training in quality and validation practices.
• Inclusive work environment that values diversity and individual merit.