Life Sciences CSV Consultant - IT Validation & Compliance

Infosys Limited; México; Remote; MXN 450,000 - 750,000; Full time

Job summary

Infosys Consulting in Mexico is seeking a Consultant in Business Consulting focusing on Computerized System Validation (CSV) for Life Sciences. You will validate IT systems, align processes with 21 CFR Part 11, GxP and GAMP 5, and support audits and client deliverables.

Responsibilities include defining development processes, authoring validation artifacts, and guiding teams on compliance and project management. Strong communication and collaboration are essential.

Qualifications

• Strong understanding of pharmaceutical compliance regulations and validation concepts.
• 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.

Responsibilities

• Create, review, and approve validation deliverables.
• Define IT system development processes (build, test, deploy, monitor) following Agile methods.
• Author major project validation deliverables per SOPs.
• Review and approve system lifecycle deliverables.
• Guide project teams on validation, security, and project management deliverables.
• Contribute to audits, assessments, or inspections.
• Escalate critical compliance findings and risks.
• Prepare management reports on compliance operations and progress.

Skills

Pharma compliance

Validation concepts

Agile methodologies

Risk management

Communication

Tools

ServiceNow

JIRA

Veeva

HPALM

Job description

Infosys Consulting in Mexico is seeking a Consultant in Business Consulting focusing on Computerized System Validation (CSV) for Life Sciences. You will validate IT systems, align processes with 21 CFR Part 11, GxP and GAMP 5, and support audits and client deliverables.

Responsibilities include defining development processes, authoring validation artifacts, and guiding teams on compliance and project management. Strong communication and collaboration are essential.