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 Medical Package – 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.
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