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Consultant - Business Consulting at Infosys in Location not listed
Mid LevelOn-siteNot specified
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. |