A well-established pharmaceutical client is looking for an IT & Validation Specialist to support system development, continuous improvements, CSV and IT projects. The role is responsible for overseeing the full lifecycle of systems, including configuration, change control, validation activities, and coordination with external IT service providers. It also drives the ongoing enhancement of business systems to ensure they remain efficient, compliant, and aligned with organisational growth. The client have a flexible approach with regards to the working arrangement being happy with a mostly remote setup, with visits to the office once every week.
Responsibilities
System development and CSV
- Manage end-to-end CSV documentation, including change control, specifications, risk assessments, and qualification deliverables (as applicable)
- Manage the preparation, execution and maintenance of CSV documentation (Change Control, URS, FS, risk assessments, test scripts, IQ/OQ/PQ where applicable)
- Perform and coordinate testing activities of system patches, updates and development activities to support CSV
- Support the validation lifecycle of systems in accordance with GAMP 5
- Contribute to IT project delivery through coordination, documentation, and stakeholder engagement
Coordination, Management & Oversight
- Oversee and coordinate external first-line IT support providers across hardware, software, systems, and user access issues
- Provide second-line IT support, including system testing, enhancements, technical troubleshooting, and resolution of escalated issues
- Coordinate device provisioning, onboarding and offboarding processes, and asset management in collaboration with IT service providers
- Manage IT support tickets, maintain documentation, and develop user guides
- Support adherence to internal IT and quality standards
- Contribute to periodic system reviews and audit readiness activities
- Ensure compliance with data integrity principles, including ALCOA+
Technical Requirements
- Experience supporting or administering enterprise or SaaS platforms such as CRM, QMS, or ERP systems
- Strong understanding of CSV - executing test scripts, IQ/OQ/PQ or UAT/Functional, documenting evidence, URS/FS
- Understanding of databases, interfaces, system integrations and CRM / ERP systems
- Interest in systems development, automation, or low-code tools is desirable
- Basic knowledge of networking concepts (LAN, VPN, user access)
- Strong problem solving and analytical skills
- Ability to communicate effectively with both technical and non-technical stakeholders
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