Welcome to Haleon.
We're a purpose-driven, world-class consumer company putting everyday health in the hands of millions.
In just three years since our launch, we've grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity.
Our trusted portfolio of brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – lead in resilient and growing categories.
What sets us apart is our unique blend of deep human understanding and trusted science.
Now it's time to fully realise the full potential of our business and our people.
We do this through our Win as One strategy.
It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do.
It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.
Quality Systems Internal Auditor This role is responsible for leading internal/ service provider and supplier audits and managing the Internal Audit (Independent Business Monitoring) Process at Haleon Dungarvan.
You will be the key point of contact / Subject Matter Expert for the Internal Audit process in both Medical Device and Medicinal sites.
You will also support external regulatory audits as required.
This is a days role.
In this role you will be responsible for Leading and managing Internal audits, Supplier and Service Provider audits in accordance with Regulatory requirements, GMP, and Haleon Quality Standards Plan, execute, and report Internal Audits and Supplier / Service Provider audits, including developing audit schedules, leading audits, creating audit plans, writing audit reports and coordinating audit responses with key stakeholders and the audit team.
Maintain and continuously improve audit procedures, tools, and methodologies.
Act as site representative for audit readiness, supporting regulatory inspections and customer audits.
Provide leadership and mentoring to audit teams, ensuring competency development and adherence to best practices.
Monitor and report audit metrics, compliance trends, and risk indicators to Senior Leadership Team.
Support implementation and maintenance of the Haleon Quality Management System and risk management processes.
Area Quality Representative support to other departments Support Risk Management process Support site Quality Regulatory Intelligence process Continuous improvement in Right First Time/compliance Understanding of appropriate Directives, Standards, Quality Managements Systems related to the manufacture of Medical Device and Medicinal products for required markets; as below: EN ISO ***** :**** +A11 :****.
EU Medical Device Regulation ********.
Ministerial Ordinance Act No. 169 of ****, as revised December ****.
Pharmaceutical and Medical Device Act, *****) PMDA Japan.
Technical Regulations for Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine October 2nd, ****, No.753.
U.S. Food and Drug Administration 21 CFR Parts 210, 211 and 820.
Korean Good Manufacturing Practice (GMP) for Medical Devices (Ministry of Food and Drug Safety) *****).
China Good Manufacturing Practice for Medical Devices.
Eudralex Volume 4 Good Manufacturing Practice (GMP)