Quality Compliance Specialist

Uniphar - Who we are

With a workforce of more than 3000 employees spread across Ireland, United Kingdom, Mainland Europe, MENA, and the USA, Uniphar is a trusted global partner to pharma and MedTech manufacturers, working to improve patient access to medicines around the world. Uniphar provides outsourced and specialised services to its clients, leveraging the strong relationships with 200+ of the world's best known pharmaco-medical manufacturers across multiple geographies, enabled by our cutting-edge digital technology and our highly expert teams. Uniphar is organised into three key divisions: Supply Chain Retail & On Demand, Uniphar Med Tech and Uniphar Pharma.

Supply Chain & Retail

Supply Chain Services provides both pre-wholesale and wholesale distribution of pharmaceutical, healthcare and animal health products to pharmacies and hospital nationwide. The business supports a diverse customer base through the provision of strong service levels coupled with innovative commercial initiatives. In addition, the business provides services and supports that help independent community pharmacy to compete more effectively in an increasingly difficult environment and runs a network of Uniphar-owned pharmacies under the Life, Allcare, McCauleys and Hickeys symbol brands.

Pharma - On Demand

The On-Demand business is a specialist medical supply business that sources and distributes pharmaceuticals, medical equipment, and consumable supplies to healthcare professionals in over 160 countries worldwide. We have offices in Ireland, UK, Europe, USA and New Zealand. The company's main divisions encompass everything from International Sales through Sales to NGO's and Charities, Clinical Trials Supply, Imported (Unlicensed Medicines), Sexual Health Supplies, and the storage and distribution of medical products and devices for third parties.

Click here to find out more: About Us - Who we are | Uniphar

Culture at Uniphar

Uniphar is a combination of many businesses each with its own identity, culture, values, and ways of working. Our overarching culture narrative is inclusive of each of these stores. Uniphar lives and breathes four key pillars which unpin and support our culture.

We have a people first approach - we do the right thing. We support entrepreneurial spirit where adaptability, commitment & resilience is embodied in our way of working. We have a Common Purpose that connects our diversified businesses and people. Finally, Trust is at the heart of how we operate.

Everything Uniphar does is enabled by our people and as we continue to grow domestically and internationally, we become more diverse. This diversity fuels our business and culture.

Sustainability

Sustainability is at the core of what we do and is deeply embedded in our business strategy. We want to contribute positively to the people and the world around us. Running our business in a sustainable way ensures that Uniphar will continue to prosper in the long-term. We are focused on ensuring that each of the five pillars of our sustainability strategy are a fundamental part of our decision-making process.

The Role

The role will support the Durbin Ireland Business in maintenance of the QMS along with the development and implementation of processes and systems to maintain with Wholesale Activities, Medical Device Regulation and ISO IS0 9001, 2015 compliance. The role will require a systematic and thorough approach to achieving regulatory compliance through the processes of Training Management, Deviation management, Quality Risk Assessment and Change Management. The incumbent will support the RP in the management of audits and inspections and be the day-to-day point of contact for all quality matters such as sub-contractor management and relationships with bot internal and external stakeholders.

MAIN DUTIES & RESPONSIBILITIES

• Support the maintenance of the Electronic Quality Management System across the Durbin Ireland and support the quality team in achieving KPI targets
• Development of policies and procedures as they relate the business processes
• Support the quality team in the management of deviations and CAPAs, risk management and change control
• Support the audit and Inspection program in conjunction with RP
• Support the ISO certification process in conjunction with Group Quality
• Assist with the integration of QMS into Uniphar Business Units
• Assist with compilation and analysis of data associated with performance of the Quality System (e.g. Management Reviews)
• Assist with the training of business units on quality and compliance matters
• Support monthly reporting of metrics associated with the Quality Management System
• Accountable for completing activities within required timelines
• Proactively highlight any issues around compliance.
• Willingly accepts challenging assignments
• Build day to day working relationships with key internal and external stakeholder
• Maintain QMS procedures to support Medical Device regulatory compliance