Life Sciences CSV Consultant - Agile Validation & Compliance

Infosys Limited

Monterrey

On-site

MXN 450,000 - 750,000

Full time

3 days ago

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Job summary

Infosys Consulting is seeking a Consultant in Life Sciences to drive Computerized System Validation (CSV) for client projects. You will define and implement IT validation activities, collaborate with multi-disciplinary teams, and ensure regulatory compliance across releases.

The role emphasizes Agile delivery, risk management, and strong communication while supporting audits and inspections within the Life Sciences domain. Based in Monterrey, it offers growth in a global consulting environment.

Qualifications

Good understanding of 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 to support multiple projects in complex environments.
IT background preferred to understand program complexities.
Collaborative attitude.
Candidates authorized to work in Mexico without visa sponsorship.

Responsibilities

Create, review, and approve validation deliverables.
Define IT system development processes (build, test, deploy, monitor) following Agile, ensuring compliance.
Work with Agile/JIRA, Confluence, ALM.
Author major project validation deliverables per SOPs.
Review and approve system lifecycle deliverables generated by project teams.
Guide teams on validation, security, and project management deliverables.
Contribute to audits, assessments, or inspections.
Escalate critical compliance findings and risks.
Prepare management reports regarding compliance operations.