Consultant- Computerized System Validation, Life Sciences- Business Consulting

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

Consultant- Computerized System Validation, Life Sciences- Business Consulting

Domain

Consulting

Interest Group

Infy Mexico

Company

Requisition ID

154350BR

Consultant, 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 Consultant 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 tools like ServiceNow, JIRA, Veeva, HPALM.
• Ability to manage multiple projects and adapt to complex environments.
• IT background preferred to understand program complexities.
• Excellent communication and collaboration skills.

About Us

Infosys Consulting is a next-generation consulting partner that bridges strategy and execution. With an AI-first mindset, deep industry knowledge, and the combined strengths of business and technology consulting, it helps enterprises turn bold vision into tangible outcomes, faster, smarter, and at scale. Infosys Consulting is helping some of the world's most recognizable brands transform and innovate. Our consultants are industry experts that lead complex change agendas driven by disruptive technology. With offices in 20 countries and backed by the power of the global Infosys brand, our teams help the C-suite navigate today's digital landscape to win market share and create shareholder value for lasting competitive advantage

EEO

Infosys provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.