IT Quality Manager

Job ref: ITQM300924 Job type: Permanent Location: Newry Closing date: Monday 14 Oct 2024 17:00 Develop, implement and maintain the policies, procedures, work instructions and any other guidance documents that comprise the Computer Systems element of the QMS to the required regulatory standards (e.g. GAMP / EU Annex 11 / 21 CFR Part 11). Liaise with the Quality function to ensure the Computer Systems element of the QMS is aligned with the overall QMS. Liaise with IT staff to ensure activities are performed in compliance with the Computer Systems element of the QMS. Liaise with appropriate industry groups to leverage and influence industry best practices and standards. Advise on the interpretation and application of regulations and guidelines affecting the Computer Systems element of the QMS (and integrate regulatory changes where appropriate and required) Leverage industry best practice and standards (e.g. ITIL / PRINCE / TOGAF / ISO27001) where appropriate and integrate them into the Computer Systems element of the QMS. Ensure Computer Systems are evaluated, risk assessed, and a risk based verification and test strategy is developed and managed to deliver all associated requirements to a high quality standard within agreed timelines. Manage verification and testing in accordance with the approved Test Plans, Test Protocols and Change Plans. Ensure that issues or defects related to systems under test are identified and resolved. Ensure that a periodic review plan is developed, maintained and executed to ensure the systems remain in a qualified or validated state. Support customer audits and regulatory inspections and respond to observations when requested. Participate in IT projects to provide Computer Systems related QMS advice and guidance. Ensure IT deviations, CAPAs and Change Controls are identified, managed and tracked to completion. Ensure IT activities are completed in accordance with GxP requirements and standards (GMP, GLP, GCP and GPvP) and IT SOPs. Conduct supplier audits on key IT suppliers to ensure their QMS and processes integrate seamlessly with our QMS and complies with our GxP obligations. Conduct regular IT quality and compliance assessments to ensure the effective application and use of the Computer Systems element of the QMS. Serve as a subject matter expert (SME) in Computer Systems Validation (CSV) and GAMP / EU Annex 11 / 21 CFR Part 11 for the IT function. Complete all work in accordance with GxP requirements (GMP, GLP, GCP and GPvP) and any required standards using the appropriate SOPs, methods and tools. Any other duties deemed necessary by management. Essential Criteria: BSc in Computer Science, Information Technology or related subject(s) OR equivalent work experience. Experience in writing standard operating procedures or work instructions. Experience coordinating and leading test teams and activities across different user groups. Ability to translate regulatory guidelines into practical activities. Good communication, time management and organisational skills. Desirable Criteria Experience: working in a pharmaceutical manufacturing or other regulated environment. working with third party IT service providers. with IT Service Management frameworks (e.g. ITIL V3) and tools (e.g. Service Now). with IT Project Management frameworks (PMP / PRINCE) and tools (MS-Project). with IT Risk Management & Compliance frameworks and tools. with Testing frameworks and tools. To Apply Please forward your CV via the APPLY Now button below.