Analyst–Computer System Validation-Life Sciences

Analyst, Business Consulting – Computer System Validation- Life SciencesWe 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 progressBasic 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 UsInfosys 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 cultureEEOInfosys 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.