Analyst, Business Consulting – Computer System Validation- Life Sciences

We are looking for smart, self-driven, high-energy people with intellectual curiosity and passion for excellence; specifically, we are looking for candidates at Analyst levels who are experienced in IT Computerized System Validation (CSV) within Life Sciences domain.

Responsibilities

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

Basic Skills & Experience

Good understanding of key 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.
Preferable IT background to understand complexities on the program.
Collaborative attitude.
Candidates authorized to work for any employer in Mexico without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time

Required Skills & Experience

Strong understanding of pharmaceutical compliance regulations and validation concepts.
Experience with Agile and Waterfall methodologies.
Familiarity with

📌 Analyst–Computer System Validation-Life Sciences (Ciudad de México)
🏢 Infosys
📍 Ciudad de México