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.
