IT Quality Service Manager
5 days ago
At Norbrook, we are seeking an experienced IT Quality Service Manager to join our team. As a key member of our IT department, you will be responsible for ensuring the quality and compliance of our computer systems.
Key Responsibilities:- Develop, implement, and maintain policies, procedures, and work instructions for the Computer Systems element of the Quality Management System (QMS).
- Liaise with the Quality function to ensure alignment with the overall QMS.
- Advise on the interpretation and application of regulations and guidelines affecting 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.
- Manage verification and testing in accordance with approved Test Plans, Test Protocols, and Change Plans.
- 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 comply 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.
- BSc in Computer Science, Information Technology, or related subject(s) or equivalent work experience.
- Experience in writing standard operating procedures or work instructions.
- Ability to translate regulatory guidelines into practical activities.
- Good communication, time management, and organisational skills.
- Experience working in a pharmaceutical manufacturing or other regulated environment.
- Experience working with third-party IT service providers.
- Experience with IT Service Management frameworks (e.g. ITIL V3) and tools (e.g. Service Now).
- Experience with IT Project Management frameworks (PMP / PRINCE) and tools (MS-Project).
- Experience with IT Risk Management & Compliance frameworks and tools.
- Experience with Testing frameworks and tools.
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