Job Summary/Main Purpose

The IT Specialist – IT Operations is responsible for providing advanced technical support and ensuring stable IT operations across the organization. The role focuses on troubleshooting, resolving escalated issues, supporting ITIL processes, administering Office 365, assisting with cloud-based environments, and ensuring compliance with pharmaceutical industry standards (GxP, GMP, CSV, 21 CFR Part 11). This role requires hands-on expertise, attention to detail, and strong collaboration with business units and Quality Assurance teams to ensure validated systems remain compliant and operational.

Main Responsibilities

Manage and ensure Computer System Validation (CSV) activities/tasks for new and existing IT systems in alignment with GAMP 5 and regulatory requirements.
Participate in IT audits and ensure IT Audit compliance.
Follow, support and ensure IT and related process remain compliant
Prepare and review validation documentation including
Collaborate with team members, business and relevant stakeholders to meet business requirements.
Ensure IT systems meet data integrity, audit trail, and electronic record/e-signature (ERES) requirements.
Coordinate with Quality Assurance, manufacturing, and external vendors for validation planning and execution.
Support to manage application upgrades, patching, and change control in compliance with ITIL and GMP standards.
Provide Level 2 technical support for escalated IT issues (hardware, software, networks, and applications).
Troubleshoot and resolve advanced problems in Office 365 (Exchange Online, SharePoint, Teams, OneDrive).
Support ITIL processes (Incident, Problem, Change, Service Request) and maintain proper documentation.
Provide L2 support for GxP/GMP systems, ensuring issues are logged, resolved, and documented per compliance needs.
Ensure IT systems comply with 21 CFR Part 11 and data integrity requirements.
Support end-user training on IT systems and act as a key contact for escalated IT service desk tickets.
Maintain IT Asset records, participate in Physical Asset verification programs and support hardware/software lifecycle management.
Oversee and ensure the smooth operation of the IT ticketing solution.
Ensure that support tickets are properly logged, categorized, prioritized, and resolved in a timely manner.
Ensure proper recording and tracking of all IT assets in the asset management system.
Perform periodic IT SOP tasks, activities to ensure compliance.
Collaborate with QA, IT Security, and business stakeholders to ensure IT operations meet regulatory expectations.

Requirements (Knowledge, Skills & Attributes)

Qualifications & Essential:

Bachelor's degree in IT, Computer Science, or equivalent.
5+ years of IT operations experience, with at least 2–3 years in L2 support.
Strong knowledge of ITIL processes and ticketing tools (e.g., ManageEngine).
Hands-on experience in Office 365 administration.
Good Knowledge in excel applications and expert in PowerPoint presentations.
2 – 3 Years experience in Pharma industry, with exposure to GxP, GMP, CSV, and regulatory compliance (21 CFR Part 11).
Good understanding of IT security policies and controls.
Strong problem-solving and communication skills.

Preferred Certifications

ITIL V4 Foundation certification.
GAMP 5 / CSV Training/Certification
Microsoft 365 certifications (MD-100, MS-700, MS-100).

Specialist - IT Operations

Job Type