Qualified Person

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 2001/83/EC and Article 51 of Directive 2001/83/EC, as amended. Notice is taken of the arrangements referred to in Article 51(2) of Directive 2001/83/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 and Veterinary Use
• Understanding of Quality Risk Management.
• Understanding of Consumer Complaint, Laboratory Investigation and Deviation Processes.
• QPs must have sufficient experience and seniority to make decisions without undue pressure.
• QPs have duties not only to their employer but also to the HPRA/Regulatory Authorities, in particular its Inspection, Enforcement and Standards. QPs must ensure that appropriate senior site leadership team managers are made fully aware of any manufacturing and/or testing issues that may cast doubt on the certification of batches or may necessitate a product recall.

People Management Responsibilities

• Excellent communication/interpersonal skills with a strong affiliation with consumer support.
• Work within a value/product stream environment.
• Assist all Quality and Manufacturing functions in preparation for, and during external agency audits and internal Haleon audits.

Problem Solving

• Ability to think strategically and use sound judgment.
• A champion of change to improve systems and processes.
• Play a key role during investigations into significant incidents that have resulted in non-conforming products or compliance failures.
• Demonstrated ability to effectively plan work and to manage projects.
• Ensure effective problem-solving system is used to prevent recurrence of issues.
• Be the focal point of problem solving within the Value Streams when the situation demands it.
• The QP must apply sound knowledge and understanding of the relevant steps of manufacture.

Required Skills Sets & Experience:

• Third level Degree in Pharmacy A pharmacy degree obtained outside of Ireland with the following:

• Evidence of Pharmaceutical Society of Ireland (PSI) registration.
• A letter from the EU competent authority where the pharmacy degree was pursued which states the candidate’s degree meets the educational requirements of Article 49 of EU Directive 2001/83/EC.

• Primary or Higher Third Level Medical, Health or relevant Science based level 8 Degree.

If the science based degree is obtained outside of Ireland, evidence that the course is recognised as meeting a level 8 degree must be provided.

With

• A recognised third level course as listed in HPRA Guide to Attainment of Qualified Person Status in Ireland: Educational Requirements, Training and Licensing (AUT-G0080).

OR

• A completed postgraduate QP eligibility course in another EU Member State, that satisfies the educational requirements. With documentary evidence from the competent authority in the Member State where the studies were undertaken, indicating that it recognises the course as fulfilling the educational requirements as defined in EU Directive 2001/83/EC.

Additional Requirements

• 5 years’ experience in a pharmaceutical/ healthcare company in the relevant Operational Quality/Quality Control Departments at a site which holds a MIA within the European Union (EU). Note, that the experience is only relevant where the MIA is valid within the EU.
• People management skills essential to lead a group of educated, skilled professionals.
• High level of knowledge and experience required to understand the manufacturing processes, Quality Control processes, Quality Assurance processes and Quality Management  System on site to ensure appropriate procedures are in place and being adhered to

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/
At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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