IT System Specialist (Pharma / GxP Environment)

Key Responsibilities

• Plan and execute end-to-end IT system retirement activities, from initiation through closure, ensuring adherence to defined timelines and compliance standards
• Manage and coordinate change control processes, including preparation and review of required documentation and protocols
• Collaborate with business stakeholders, IT teams, and external vendors to ensure smooth and compliant execution of system decommissioning activities
• Lead investigations and resolution of discrepancies identified during execution, ensuring proper documentation and closure in line with regulatory expectations
• Maintain and manage electronic protocol documentation using relevant tools and systems
• Track project progress, identify potential risks, and proactively implement mitigation strategies
• Provide regular status updates to project leads and stakeholders, ensuring transparency in delivery and timelines
• Ensure all activities comply with GxP, data integrity, and audit requirements within a regulated environment

Key Requirements

• Bachelor’s Degree in Information Technology, Life Sciences, or a related field
• Minimum 5 years of experience in pharmaceutical or regulated industries
• Proven experience in IT system retirement, decommissioning, or lifecycle management activities
• Hands-on experience with electronic protocol management tools and documentation processes
• Working knowledge of the following systems:
• Veeva Vault
• ServiceNow
• Acronis
• Windows operating systems
• Familiarity with Commercial Off-The-Shelf (COTS) applications and Software Development Life Cycle (SDLC) processes
• Strong understanding of regulatory compliance, data integrity, and validation requirements (e.g., GxP)
• Excellent stakeholder management and cross-functional coordination skills
• Ability to work independently, manage multiple priorities, and deliver within strict timelines

Preferred Qualifications

• Experience working in global pharmaceutical or life sciences organizations
• Exposure to system validation, audit support, or regulatory inspections
• Familiarity with ITIL or structured IT service management frameworks