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Quality systems internal auditor

Dungarvan
Haleon
Internal auditor
Posted: 26 February
Offer description

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 forLeading and managing Internal audits, Supplier and Service Provider audits in accordance with Regulatory requirements, GMP, and Haleon Quality StandardsPlan, 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 departmentsSupport Risk Management processSupport site Quality Regulatory Intelligence processContinuous improvement in Right First Time/complianceUnderstanding of appropriate Directives, Standards, Quality Managements Systems related to the manufacture of Medical Device and Medicinal products for required markets; as below:EN ISO 13485 :2016 +A11 :2021.EU Medical Device Regulation 2017/745.Ministerial Ordinance Act No. 169 of 2004, as revised December 2022.Pharmaceutical and Medical Device Act, PMDA Japan.Technical Regulations for Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine October 2nd, 2013, 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) & applicable annexesICH Guidelines.Halal Product Assurance System (HPAS).Perform duties in a compliant manner and behave in accordance with Haleon Quality Management System requirements.Participate fully in our site's quality initiatives and ensure that all relevant quality standards are adhered toMaintain GMP standards where appropriate to your roleRead and understand relevant Haleon Quality Standards and SOPs applicable to roleAttend training and complete assessments as requiredEnsure Quality and GMP are at the forefront of changes proposedEnsure Halal requirements are met in accordance with General Guidelines of Halal Product Assurance System for applicable Medical Device products/marketsSupport site HAPs projectsAbility to communicate with a wide variety of people at all levels both within the site and externally through appropriate skills: - Verbal / written, Negotiation, Report writing, presentation, Empathy / affiliation and listening.Demonstrated ability to problem solveDemonstrated ability to effectively plan work and to manage projectsWhy you?Basic QualificationsWe are looking for professionals with these required skills to achieve our goals:A degree in science or an equivalent disciplineMinimum 5 years audit experienceThe candidate must have in‑depth understanding of global pharmaceutical regulations, such as:Core GMP / GxP RegulationsFDA 21 CFR Parts 210–211, 820EU GMP Guidelines including Annex 1, Annex 11ICH Guidelines (ICH Q7, Q8, Q9, Q10)The candidate must understand requirements for supplier qualification and auditing as mandated by:EU GMP Chapter 5.29Directive 2001/83/EC (active substance supplier audits)Requirements for auditing packaging, testing labs, and outsourced activitiesPreferred Qualifications/ ExperienceIf you have the following characteristics, it would be a plus:Ability to communicate with a wide variety of people at all levels both within the sites and Haleon and externally through appropriate skills: - Verbal / written, Negotiation, Report writing, presentation, Empathy / affiliation and listeningDemonstrated ability to problem solveDemonstrated ability to effectively plan work and to manage projectsWhy HaleonBecome part of one of Haleon's largest global manufacturing sites, producing leading brands like Panadol and Poligrip for over 80 markets worldwide. Enjoy a strong sense of community built over more than 40 years in Dungarvan, with a proud, supportive workforce and excellent training that helps you grow from day one. Haleon continues to invest heavily in modern automation, upgraded labs and sustainability — achieving net‑zero carbon status ahead of schedule — making it an exciting, future‑focused place to build your career. Employees highlight great teamwork, fair management, valuable learning opportunities and competitive pay supported by union-negotiated increases. Join a company committed to improving everyday health for millions while supporting long-term employment in the local community.Job Posting End Date Equal OpportunitiesHaleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. It's important to us that Haleon is a place where all our employees feel they truly belong.During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees.The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions.Adjustment or Accommodations RequestIf you require a reasonable adjustment or accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific adjustments you are requesting. We'll provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence.Note to candidatesThe Haleon recruitment team will contact you using a Haleon email account ). If you are not sure whether the email you received is from Haleon, please get in touch.

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