Key Responsibilities
Provide IT support for bioanalytical systems and end users
.Participate in system/software validation activities, execution, and documentation.
Manage IT server and system backup and restoration as per approved SOPs.
Perform and document weekly, monthly, and yearly backups, including backup integrity verification.
Manage and support IT incidents and response activities in coordination with QA, other stakeholders, and vendors.
Review and update IT SOPs, including amendments and revisions, and coordinate departmental review and approval.
Initiate and manage Change Control, Deviation, and CAPA processes for IT-related activities.
Maintain and archive logbooks, forms, formats, PTRs, and other IT records.
Support system/data restoration and IT requirements during sponsor, customer, and regulatory audits.
Provide IT support for servers, storage, hardware,



software, and user applications as required.
Support FTP site creation, access management, data transfer, and troubleshooting.
Manage project folders, access rights, and project data archival. Monitor server and storage disk space and take preventive action where required.
Provide Helpdesk and ICT support and coordinate issue resolution with vendors.
Lead and coordinate IT activities and support team management. Regulatory & Compliance Knowledge
US FDA 21 CFR Part 11
EU Annex 11
GAMP 5 Guidelines
Computerized System Validation (CSV)
Data Integrity and Valuable Documentation Practices
Change Control, Deviation, CAPA, and Incident Management

📌 It Administration Executive Ahmedabad
🏢 Veeda CR
📍 Ahmedabad