Job Title:
Quality Management System (QMS) Specialist
About Uniphar:
Uniphar Group is a rapidly expanding diversified healthcare services business with a global footprint and a proud heritage in Ireland.
The Group has grown organically and through strategic acquisitions, strengthening its international reach since becoming a publicly listed company in 2019.
Uniphar provides outsourced and specialised services to clients, leveraging strong relationships with over 200 pharmaco-medical manufacturers across multiple geographies, enabled by cutting-edge digital technology and expert teams.
Organised into three key divisions: Supply Chain & Retail, Commercial & Clinical (Med Tech / Pharma), and Product Access.
A workforce of nearly 3,500 spans Ireland, the UK, the Netherlands, the Nordics, Germany, and the USA.
Uniphar is a trusted partner to Pharma and MedTech manufacturers, improving patient access to medicines and treatments worldwide.
Culture at Uniphar:
We value entrepreneurial spirit, innovation, collaboration, and problem-solving ethos.
This approach enables long-term relationships with leading Pharma and MedTech companies.
We treat customers and patients with integrity and respect, prioritising their needs in our operations.
Our people drive everything we do, fostering a diverse culture that fuels growth and enriches our business.
Objective:
Support the maintenance of QMS across Uniphar Businesses, ensuring compliance with GxP requirements and ISO 9001 2015 standards.
Maintain a systematic approach to regulatory compliance through deviation management, quality risk assessment, and change control.
Main Duties & Responsibilities:
* Support Electronic Quality Management System maintenance and quality team KPI targets.
* Manage deviations and CAPAs, risk management, and change control with the quality team.
* Act as Deputy Responsible Person for Wholesale Distribution Authorisations.
* Assist in preparation for Regulatory and Client Audits.
* Support ISO certification process for Group entities.
* Integrate QMS into Uniphar Business Units.
* Analyse data for Quality System performance (e.g., Management Reviews).
* Maintain Licenses, including Manufacturing licenses and Wholesale Distribution Authorisations.
* Train business units on quality and compliance matters.
* Report monthly metrics associated with the Quality Management System.
* Complete activities within required timelines.
* Highlight compliance issues proactively.