<p>Job Description</p> <p>Senior Consultant, Business Consulting - Computer System Validation- Life Sciences</p> <p>We are looking for smart, self-driven, high-energy people with intellectual curiosity and passion for excellence; specifically, we are looking for candidates at Senior Consultants levels who are experienced in IT Computerized System Validation (CSV) within Life Sciences domain.</p> <p>Responsibilities:</p> <ul> <li>Create, review, and approve validation deliverables </li><li>Define IT system development processes (build, test, deploy, monitor) following Agile ways of working and ensure followed compliance in each release /Iteration </li><li>Working experience on Agile/JIRA, Confluence, ALM </li><li>Author major project validation deliverables as per client's standard operating procedures </li><li>Review and approve system lifecycle deliverables generated by project team </li><li>Guide project teams on applicable validation, security, and project management deliverables </li><li>Advise project team on implementation of compliance and security control requirements at the appropriate stages of system development </li><li>Contribute to internal and external audits, assessments, or inspections </li><li>Escalate critical compliance findings, risks, or issues into appropriate client units </li><li>Prepare management reports regarding compliance operations and progress </li></ul> <p>Basic Skills & Experience</p> <ul> <li>5 plus years of professional experience in the Life Sciences industry working for a consulting services organization and/or industry. </li><li>Good understanding of key pharmaceutical compliance regulations like 21 CFR Part 11, GxP and GAMP 5. </li><li>Experience creating, reviewing and approving validation deliverables. </li><li>Knowledge of risk management processes. </li><li>Thorough knowledge in compliance and validation concepts. </li><li>Proven ability in supporting multiple projects, responding quickly to changing situations in complex environments. </li><li>Preferable IT background to understand complexities on the program. </li><li>Collaborative attitude. </li><li>Location: New York, New Jersey, Indianapolis </li><li>Candidates authorized to work for any employer in US without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time </li></ul> <p>Required Skills & Experience</p> <ul> <li>Strong understanding of pharmaceutical compliance regulations and validation concepts. </li><li>Experience with Agile and Waterfall methodologies. </li><li>Familiarity with tools like ServiceNow, JIRA, Veeva, HPALM. </li><li>Ability to manage multiple projects and adapt to complex environments. </li><li>IT background preferred to understand program complexities. </li><li>Excellent communication and collaboration skills. </li></ul>