Life Sciences CSV Analyst - Compliance & Validation

Infosys Limited; Ciudad de México; Presencial; MXN 600.000 - 1.000.000; Jornada completa

Descripción de la vacante

Infosys Limited in Mexico City seeks an Analyst for Computer System Validation in Life Sciences. You will validate IT systems, collaborate across teams, and ensure compliance in rapid, Agile-driven releases.

This role focuses on delivering validated lifecycle artifacts, risk assessments, and audit readiness across projects. Strong knowledge of pharmaceutical regulations, validation concepts, and experience with tools like JIRA, Confluence, and ALM is preferred.

Formación

• Good understanding of pharmaceutical compliance regulations like 21 CFR Part 11, GxP and GAMP 5.
• Experience creating, reviewing and approving validation deliverables.
• Knowledge of risk management processes.
• Thorough knowledge in compliance and validation concepts.
• Proven ability in supporting multiple projects, responding quickly to changing situations in complex environments.
• Collaborative attitude.
• Candidates authorized to work for any employer in Mexico without employer-based visa sponsorship are welcome to apply.

Responsabilidades

• Create, review, and approve validation deliverables
• Define IT system development processes (build, test, deploy, monitor) following Agile ways of working and ensure followed compliance in each release /Iteration
• Working experience on Agile/JIRA, Confluence, ALM
• Author major project validation deliverables as per client’s standard operating procedures
• Review and approve system lifecycle deliverables generated by project team
• Guide project teams on applicable validation, security, and project management deliverables
• Contribute to internal and external audits, assessments, or inspections
• Escalate critical compliance findings, risks, or issues into appropriate client units
• Prepare management reports regarding compliance operations and progress

Conocimientos

Pharma compliance

Validation concepts

Agile methodologies

Waterfall methodologies

Risk management

Communication skills

Collaboration

IT background

Herramientas

ServiceNow

JIRA

Veeva

HPALM

Confluence

ALM

Descripción del empleo

Infosys Limited in Mexico City seeks an Analyst for Computer System Validation in Life Sciences. You will validate IT systems, collaborate across teams, and ensure compliance in rapid, Agile-driven releases.

This role focuses on delivering validated lifecycle artifacts, risk assessments, and audit readiness across projects. Strong knowledge of pharmaceutical regulations, validation concepts, and experience with tools like JIRA, Confluence, and ALM is preferred.