I am an IT professional with over 14 years of hands-on experience in the pharmaceutical industry, specializing in GxP Information Systems, Computerized System Validation (CSV), and Data Integrity. Currently, I serve as Assistant Manager – IT at SMS Life Sciences India Ltd, where I focus on making GxP -complaince information handling within Manufacturing, Laboratory, and Facilities simpler, streamlined, and audit-ready. My expertise spans across multiple domains, including Electronic Data Compliance (Part-11, Annex-11, GAMP5), Risk-based Validation Strategies, and Scientific Application Implementations. I lead and manage the creation of validation documentation like Validation Master Plans, Traceability Matrix, SOPs, and Risk Assessments, ensuring all systems are in line with the highest industry standards. Over the years, I've contributed to the implementation and optimization of IT services within pharma environments, helping businesses stay compliance and achieve operational efficiency. I am passionate about leveraging IT solutions to support compliance, improve productivity, and align technology with business goals. With a strong foundation in Electrical Engineering, IT Administration, and Scientific Software Implementation, I thrive in roles that require both technical expertise and regulatory knowledge to solve complex challenges and drive organizational success. Key Skills and Expertise: IT Administration: System administration, user management, troubleshooting, hardware/software installation. Laboratory IT Systems: "Empower 3.6.1", "OpenLab CDS", "OpenLab EZ Chrome", Lab Solution, and Chromatography systems (HPLC, UPLC, GC, etc.). Data Management: "Backups", "restorations", "Data security", "Audit trail" verification. Networking & Security: Network troubleshooting, firewall configuration, antivirus/patch management. Regulatory Compliance: Part 11 "compliance", "Audit" Participation ("USFDA", "GMP", "KFDA","PMDA"). End-User Support: Technical assistance, software installation, system upgrades. Hardware Maintenance: Repair and maintenance of critical IT hardware, including servers, desktops, and peripherals. Training & Documentation: SOP creation, user training, technical documentation, and reporting.