MX/ Analyst LS CSV

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 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 the global management and technology consulting practice of Infosys, a global leader in technology services and consulting. We combine the power of time-tested methodologies, people-driven innovation and disruptive technology to enable leaders of the world’s top brands pursue a path of smart transformation. Together with our clients, internal and external partners, we co-create and execute pragmatic strategies and solutions that transform organizations and define the future of business. Our dynamically growing consultancy offers our consultants:
• Ability to design and implement end-to-end solutions at scale
• A flat organization structure with direct access to our senior-most leaders
• An entrepreneurial environment full of bright, highly motivated consultants
• Opportunities for motivated consultants to impact local communities
• The ability to design your career and drive your professional learning and development
• A truly global culture

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.