Senior OQ Coordinator

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.

Here in Haleon Dungarvan we are looking for a Senior OQ coordinator OTC, this person is responsible for providing day to day management of quality improvement activities and regular dealings with Production areas to discuss issues and action deviations/complaints.

To support all quality systems associated with Operational Quality - Documentation, deviations, complaints, rFT, service providers.

To Liaise with manufacturing and support services ensuring effective problem-solving to prevent recurrence of issues and therefore reduce waste.

Key Responsibilities:

• Perform duties in a compliant manner and behave in accordance with our Quality Management System requirements and participate fully in our site's quality initiatives and ensure that all relevant quality standards are adhered to.
• NPI review and Project work
• Review of deviations and customer complaints
• Quality representative during Root Cause analysis as well as triage stage of deviations.
• Support regulatory inspections and internal audits.
• Supporting Site Improvement Project and Site Quality Council.
• Supporting Metrics for monthly OQ Area Quality Meeting.
• Deviation and reject sections for PPR
• Management of our service providers Oasis, Cappoquin logistics and Q1 Scientific.
• nRFT tracking and supporting Zero defects as required.
• Supporting OQ coordinators in advising of red lanes and working with man ops in quality improvements.

Essential Qualifications & Skills we are looking for:

• Third Level Science based qualification
• 5 years experience in pharma or in a healthcare company
• Understanding of appropriate directives, standards, policies and guidelines and ability to implement appropriately,
• Directive 2001/83/EC
• QMS
• EU GMP
• cGMP (CFR 210/211, 820)
• EN ISO 13485:2016
• European Medical Device Regulation 2017/745
• Pharmaceutical Affairs Law Japan
• MHLW Ordinance No. 169
• MHLW Ordinance No. 2
• GSK Facility & Technical Process Guides
• Understanding of relevant regulatory requirements for all markets.
• Understanding of quality systems. Knowledge of all products and manufacturing processes.
• Intimate knowledge of SAP and demonstrated use of the respective application for data analysis and continuous improvement

Why Haleon?

None of us should ever feel like we are standing still. Instead, we want Haleon to be a place where we feel like we are always progressing.

Improving everyday health takes Dedication. Energy. Effort. So we look to reward your contribution with a benefits package that includes but not limited to:

• Annual bonuses that reflect Haleon's performance
• Hybrid@Haleon - our philosophy to hybrid work and supporting individuals work/life balance
• Childcare support - we offer enhanced maternity and paternity paid leave options for those important times as well as child care options
• Life Insurance and Private MedicalPackage - with additional preventive healthcare services for employees to provide protection and piece of mind
• Health and Wellbeing - programmes that take care of you physically and mentally
• Development Opportunities - future-ready training, so your skills are always up to date within your role and company's structure

Care to Join Us?

Apply now to hear more about this role and our journey changing the future of everyday health.

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.
As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon's compliance to all federal and state US Transparency requirements.