IT Administration Executive

Veeda CR; Ahmedabad District; On-site; INR 700,000 - 1,200,000; Full time

Job summary

Veeda CR seeks an IT specialist to support bioanalytical systems and end users. You will participate in validation activities, back up systems, manage incidents, and support audits with QA and vendors.

You will maintain SOPs, change controls, CAPAs and IT records while coordinating IT projects and data integrity across the department. Responsibilities include backup/restoration, incident management, data transfer, and ensuring regulatory compliance knowledge.

Qualifications

• Experience in IT support for bioanalytical systems and end users.
• Involvement in system/software validation activities and documentation.
• Backup management with weekly, monthly, and yearly cycles and integrity checks.
• Coordinate IT incident response with QA, stakeholders and vendors.
• Maintain and update IT SOPs and coordinate reviews.
• Initiate and manage Change Control, Deviation and CAPA processes.
• Maintain IT records, logbooks, PTRs and forms.
• Support audits (sponsor, customer, regulatory) for systems and data.
• Provide IT support across servers, storage, hardware and software.
• Assist FTP site creation, access management and data transfer.
• Manage project folders, access rights and data archival; monitor space.
• Lead IT activities and provide team coordination; ensure regulatory compliance knowledge.

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, 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 Good Documentation Practices
• Change Control, Deviation, CAPA, and Incident Management

Job description

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 Good Documentation Practices
• Change Control, Deviation, CAPA, and Incident Management