Senior Computerized System Validation Specialist (Pharma/CRO)

Truelogic; Xico; Presencial; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

Cohortias, a CRO operating in Latin America, seeks a Computerized System Validation Specialist to lead validation lifecycle activities for GxP-regulated and eClinical systems. You will own compliance across our software and IT ecosystem, developing governance, validation plans, and CSA protocols.

The role requires 5-7 years in Pharma/CRO, strong knowledge of 21 CFR Part 11, EU Annex 11, ICH guidelines, and excellent English for global audits.

Formación

• 5-7 years of QA or CSV experience within Pharma/CRO sectors.
• Authoring CSV protocols and leading GxP compliance assessments.
• Bachelor's degree in Life Sciences, Pharmacy, Computer Science, Software Engineering, or related technical field.
• Advanced English for global stakeholder and audit interactions.

Responsabilidades

• Define, implement, and maintain validation strategies and SOPs for computerized systems across their lifecycle.
• Plan, execute risk-based validation deliverables (IQ/OQ/PQ) and CSA protocols for software, cloud, and eClinical platforms.
• Conduct quality risk assessments to ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity principles.
• Oversee vendor qualification, SLAs, audit trails, and change controls with IT service providers.
• Coordinate root cause analyses, CAPA plans, and ensure audit readiness for sponsor inspections.

Descripción del empleo

Cohortias, a CRO operating in Latin America, seeks a Computerized System Validation Specialist to lead validation lifecycle activities for GxP-regulated and eClinical systems. You will own compliance across our software and IT ecosystem, developing governance, validation plans, and CSA protocols.

The role requires 5-7 years in Pharma/CRO, strong knowledge of 21 CFR Part 11, EU Annex 11, ICH guidelines, and excellent English for global audits.