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