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MX/ Analyst LS CSV - Business Consulting at Infosys in Mexico City, MX
Skills
Job Description
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.
EEO/About Us
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.