Ref No: AM17326
Co. Dublin, Ireland
Lab IT Technical Lead - Dublin West.
In this role you will work in partnership with IT, QA, CSV and QC to ensure smooth running of lab systems and regulatory compliance. Day to day operational support is another key part of the role.
Core Duties & Responsibilities:
• Provide day to day IT support of instrument systems in the labs and manufacturing areas, including tasks such as user access management, troubleshooting, preventative maintenance, data management, patch management and ensuring that systems are available 24x7 to meet business needs.
• Provide direction, support and development of the team of Lab Engineers for Lab sustaining activities.
• Ensure that all work on Lab IT and Benchtop Analytical equipment is carried out in a compliant manner, meeting 21 CFR Part 11, EU Annexe 11, cGLP/GMP’s.
• Provide day to day compliance support of IT Laboratory Systems such as user access reviews, system performance monitoring, change control, data management.
• Support the maintenance of IT systems in a state of Audit Readiness.
• Management of IT lifecycle procedures including change management, incident management, disaster recovery.
• Ensure the IT processes/procedures meet the business and site Quality Management System requirements, and their evolution/improvement to meet the changing business and compliance needs.
• Support the introduction of new instrument systems.
Experience and Key Skills Required:
• Degree in Engineering, Information Systems, Computer Science or Life Sciences.
• At least four years’ experience of working in a pharmaceutical lab environment, with strong IT experience of laboratory instrument systems.
• Technical Lead experience working in a pharmaceutical lab environment.
• Knowledge of pharmaceutical industry regulations (cGMP/cGLP, OSHA, EPA/EQB), 21 CFR 11 and EU Annex 11.
• Experience working in a GMP environment, strong change management skills and ability to manage CAPA processes.