IT Quality Service Manager
5 days ago
Permanent Location: 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.
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.
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.
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.
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.
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.
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