Life Sciences CSV Consultant – Compliance & Validation

Infosys; Monterrey; Sur place; MXN 420 000 - 640 000; Plein temps

Résumé du poste

Infosys Consulting is seeking a Consultant in Business Consulting focused on IT Computer System Validation for Life Sciences. You will create, review, and approve validation deliverables and define IT validation processes aligned with 21 CFR Part 11, GxP and GAMP 5.

This role emphasizes collaboration across project teams, audits and inspections support, and strong communication to manage risks, with Agile/JIRA/Confluence/ALM tools integral to the delivery.

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 supporting multiple projects in complex environments.
• Preferable IT background to understand program complexities.
• Collaborative attitude.

Responsabilités

• Create, review, and approve validation deliverables
• Define IT system development processes following Agile and ensure compliance in each release/Iteration
• Working experience on Agile/JIRA, Confluence, ALM
• Author major project validation deliverables as per client’s SOPs
• 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

Connaissances

Pharma compliance

Validation concepts

Risk management

Communication

Collaboration

IT background

Outils

JIRA

Confluence

ALM

ServiceNow

Veeva

HPALM

Description du poste

Infosys Consulting is seeking a Consultant in Business Consulting focused on IT Computer System Validation for Life Sciences. You will create, review, and approve validation deliverables and define IT validation processes aligned with 21 CFR Part 11, GxP and GAMP 5.

This role emphasizes collaboration across project teams, audits and inspections support, and strong communication to manage risks, with Agile/JIRA/Confluence/ALM tools integral to the delivery.