Quality Manager/Responsible Person (RP) This job description sets out the scope of the role of Quality Manager/RP the with the main duties of the position at the date when it was completed.
It does not include or define all responsibilities or duties which the post holder may be expected to carry out.
Duties may vary from time to time without changing the nature of the post or the level of responsibility.
The post holder may also be required to carry out any other duties to co-operate with the general work of the organisation, as required by their line or department manager.
Overview / Purpose of the Role United Drug wishes to recruit a Quality Manager/Responsible Person (RP) with responsibility for managing activities within Quality Assurance in accordance with the requirements of the Quality Management System, and in particular in accordance with Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) and associated legislation. Key Responsibilities: Perform the duties of deputy RP on United Drug's Wholesale Distribution Authorisations (WDA).
Manage the Quality Compliance and Temperature validation team.
Manage HPRA Inspections and principal/client audits.
Manage the activities of a Qualified Person (QP) on United Drug Manufacturing Authorisations (MIA's) Provide Quality management coordination and leadership for continuous improvement of QMS Quality Assurance elements.
Manage the Deviation Management process, conducting timely investigations, identifying root causes, and implementing effective CAPAs.
Oversee the Complaint Management process, including United Drug Pharmacovigilance for Product Quality Defects and Potential Adverse Events, as well as supporting GDP complaints.
Manage the QA role of Recall co-ordination including Field Safety Notices, CIUNs, Mock Recalls and ensure effective communication throughout; to Responsible Person, Regulator Authority, Supplier and Customers. Ensure effective Training Management processes are implemented for GDP/GMP compliance.
Coordinate the Change Management process, conducting comprehensive impact/risk assessments and ensuring timely completion of actions.
Manage the Documentation Management System - author, review and ensure that documentation is accurate and compliant with regulatory requirements.
Take responsibility for Sub-Contractor Management for United Drug GDP activities, ensuring qualification, control, periodic review and auditing.
Oversee Product/Supplier/Customer set-up and Bona-Fides.
Embed QMS Management principles, fostering an agile quality culture within the organization.
Develop and maintain a comprehensive audit readiness program to ensure internal and external compliance across 4 sites with multiple business entities through the QMS.
Build team skills through skills assessment, training, feedback, and support.
Manage the ongoing performance of direct reports.
Stay informed about developments in the quality field by reading current quality/regulatory literature and attending relevant meetings and workshops.
Key Experience / Skills / Education: Minimum of 5 years in a manufacturing or distribution environment Formal Certification as a QP is an advantage, with experience of secondary packaging processes Demonstrated track record in Quality management system improvement Working knowledge of GDP, GMP and ISO 9001:2015 Strong leadership skills, in particular performance management, observational coaching and mentoring Able to demonstrate leadership skills Highly collaborative, with ability to work constructively and positively influence and engage colleagues and internal stakeholders Excellent team player with the ability to drive groups forward to achieve one common goal Minimum Bachelor Degree in Life Science essential Track record of continuous personal development Attention to detail with a high level of accuracy About United Drug United Drug is Ireland's largest pharmaceutical distribution company and was originally founded by a group of pharmacists in Ballina, Mayo in 1948.
In 2022 United Drug became part of the PHOENIX group and is now part of Europe's leading healthcare provider in the sector.
Employing more than 650 staff across operations in Dublin, Limerick and Mayo, we partner with more than 1,900 pharmacies, hospitals, clinics and primary care centres across Ireland.
The business spans across three business units; United Drug Wholesale, United Drug Distribution and United Drug Consumer - all leaders in their category.
About PHX Ireland & PHOENIX Group As Irelands leading fully integrated healthcare provider, we are proud of our mission - We deliver health.
PHX Ireland Group employs over 1,800 talented and experienced people, all passionate about supporting their customers and patients and striving to enhance the quality of life for millions of patients every single day.
We operate 5 distribution centres, pharmacies nationwide, deliver over 85 million packs to Irish pharmacies and hospitals, and serve over 500,000 patients each year.
By working collaboratively together to provide these solutions, PHX Ireland can enable a sustainable healthcare system and support Irish Healthcare needs.
PHX Ireland is part of the PHOENIX group.
Having access to Europe's leading healthcare provider helps us grow and evolve, by adopting best practice, and sharing insights, processes, and expertise we can continuously improve our offering and drive Irish Healthcare forward.
We strive to foster an open and inclusive environment, embracing applications from individuals of all backgrounds.
Our commitment lies in ensuring an accessible interview process for all candidates.
If you require additional support or accommodations to attend an interview, we kindly encourage you to reach out to ******