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.
**Hello.
** **We're Haleon**.
A new world-leading consumer health company.
Shaped by all who join us.
Together, we're improving everyday health for billions of people.
By growing and innovating our global portfolio of category-leading brands – including **Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum** – through a unique combination of deep human understanding and trusted science.
What's more, we're achieving it in a company that we're in control of.
In an environment that we're co-creating.
And a culture that's uniquely ours.
Care to join us.
It isn't a question.Haleon is recruiting for a Qualified Person, this person will be responsible for releasing all bulk product and packaged product to market based on their Marketing and Manufacturing Authorisations and ensure all such relevant activities relating to Dungarvan comply with all GMP and Regulatory requirements.The purpose of controlling batch release is notably to ensure that the batch has been manufactured and checked in accordance with the requirements of its ManufacturingAuthorisation Holder (MAH) as per the Technical Terms of Supply (TTS) and the QualityAgreements with the Local Operating Companies (LOCs).
The role of the Qualified Person(s) as per Eudralex volume 4 – annex 16 Certification by Qualified Person and Batch Release, is as defined in Article 47 of Directive *******/EC and Article 51 of Directive *******/EC, as amended.
Notice is taken of the arrangements referred to in Article 51(2) of Directive *******/EC, as amended, e.g., Mutual Recognition Agreements (MRA), on the Community code relating to medicinal products for human use in relation to the release of bulk and finished packed product from the Haleon, Dungarvan facility.
**Responsibilities:*** Ultimate responsibility for release of all medicinal product from Haleon Dungarvan, that all batches released have been manufactured in compliance with laws in force in the member state where certification takes place and that the batch has been manufactured in accordance with the requirements of its Marketing Authorisation (MA) and with current Good Manufacturing Practice (cGMP).
* Putting the consumer/patient at the heart of every decision, driving the culture of the importance of the consumers in the organisation, where everyone understands the 'consumer is first'(whether internal or external to Haleon), and that Haleon is a patient, consumer-focused business.
* Understand all Quality systems and ensure that product is made to appropriate GMP* Ensure there is an effective problem-solving system in place to prevent recurrence of issues.
* Be the focal point of problem solving within the Value Streams when the situation demands it to ensure on-time resolution of issues to support batch release.
* Act and take decisions impartially based on legislation, official guidance, best science, facts, quality risk management principles, and without bias.
Balancing speed of decision making with considered thought in a compliant manner and behave in accordance with our Haleon Quality Management System requirements to ensure that Quality and GxP are at the forefront of all decisions.
* Ultimate responsibility for release of all medicinal product from Haleon Dungarvan, that all batches released have been manufactured in compliance with laws in force in the member state where certification takes place and that the batch has been manufactured in accordance with the requirements of its Marketing Authorisation (MA) and with current Good Manufacturing Practice (cGMP).
* Putting the consumer/patient at the heart of every decision, driving the culture of the importance of the consumers in the organisation, where everyone understands the 'consumer is first'(whether internal or external to Haleon), and that Haleon is a patient, consumer-focused business.
* Understand all Quality systems and ensure that product is made to appropriate GMP standards.
* Ensure there is an effective problem-solving system in place to prevent recurrence of issues.
* Be the focal point of problem solving within the Value Streams when the situation demands it to ensure on-time resolution of issues to support batch release.
* Act and take decisions impartially based on legislation, official guidance,* best science, facts, quality risk management principles, and without bias.
Balancing speed of decision making with considered thought in a compliant manner and behave in accordance with our Haleon Quality Management System requirements to ensure that Quality and GxP are at the forefront of all decisions.
* Ability to communicate with a wide variety of people at all levels both within the site and Haleon and externally (e.g., HPRA) through appropriate skills.
* Developing close working relationships with consumers and other key stakeholders, communicating decisions clearly aligned to the quality standards, policies and procedures.
* Being able to understand and state different perspectives, systematically evaluating different courses of action and the advantages and disadvantages of several realistic alternative solutions to issues to provide a balanced evaluation.
* Being non-evaluative and non-judgemental about understanding the views of others, encouraging mistakes and best practices to be openly discussed so that learning can occur, even if this view conflicts with your own.
* On time release of medicinal products to the marketplace to ensure consumer satisfaction.
**Environmental Health & Safety (EHS) Responsibilities*** Perform duties in a compliant manner and behave in accordance with site SOP's, Haleon EHS standards and guidelines and relevant legal requirements.
* Read and understand Standard Operation Procedures applicable to role.
* Report all accidents, incidents and any EHS issues using the appropriate process /system to your line manager or, if required, the Occupational Health Advisor.
* Maintain work area in an inspection ready state and clean as you go to maintain good safe housekeeping standards.
* Be aware of the impact of your job activities on EHS issues.
**Quality Responsibilities*** The Qualified Person is responsible for release of all medicinal product from Haleon Dungarvan.
* Perform duties in a compliant manner, ensuring that all relevant quality and GxP standards are adhered to in accordance with the Haleon Quality Management System requirements to ensure that Quality and GxP are at the forefront of all decisions, changes proposed etc.
* Read and understand the relevant Standard Operating Procedures, Global Quality Procedures, QMS Systems and appropriate Regulations & Directives relating to the role and the manufacture and supply of medicinal products.
* Attend training and complete assessments as required.
* Experience of Change management and understanding of change control process.
* Communication skills across site and organization.
* Understanding of Eudralex Volume 4 - Annex 16: Certification by Qualified Person and Batch Release.
* Understanding of HPRA Guide to Reporting and Investigation of Quality Defects in Medicinal Products for Human
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