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About the role
Bachelor's degree in IT / Computer Science / Engineering or equivalent. Location: Bangalore (Site-based) Function: IT – Scientific Informatics / Quality Systems Support Role Summary The role involves providing IT support and administration for Scientific (R&D) and Quality Control (QC) systems in a regulated (GxP) environment. The incumbent will support application availability, user management, compliance, validation activities, audits, and coordination with internal teams and vendors. Key Responsibilities Provide IT administrative support for Scientific and QC applications including user management, access control, backups, restorations, system date/time settings, and log reviews. Maintain inventory of Scientific and QC applications at the site. Prepare, update, and maintain IT SOPs and related documentation for GxP systems. Act as first-level IT support for R&D / QC users; coordinate with vendors/OEMs for incident resolution. Perform data backup and recovery activities as per approved SOPs. Support CSV activities, including 21 CFR Part 11 assessments, qualification, validation, and periodic reviews from an IT perspective. Assist during internal, customer, and regulatory audits, including documentation support, audit responses, CAPA, change controls, incidents, and deviations. Coordinate with Central IT, vendors, and cross-functional teams to resolve application and system issues. Conduct end-user training during system rollouts and on a need basis. Ensure compliance with IT policies, SLAs, quality systems, and regulatory requirements. Support continual improvement of IT service delivery for Scientific and QC systems. Key Skills & Competencies Basic knowledge of GxP, CSV, 21 CFR Part 11, SOPs, audits, and CAPA. Hands-on experience with user access management, backups, documentation, and vendor coordination. Good understanding of IT support processes in regulated environments. Strong documentation, communication, and coordination skills.
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