Consultant- Computerized System Validation, Life Sciences- Business Consulting

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.