Business Unit Quality Lead

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Business Unit Quality Lead

Apply locations CityWest Office time type Full time posted on Posted Yesterday job requisition id JR-0000004383 Who we are Uniphar Group is a rapidly expanding diversified healthcare services business with a global footprint and a proud heritage in Ireland. Since Uniphar became a publicly listed company in 2019, the Group has grown organically and through a series of strategic acquisitions, which continue to strengthen Uniphar’s international reach. 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 expert teams. Uniphar is organised into three key divisions: Supply Chain & Retail, Commercial & Clinical (Med Tech / Pharma) and Product Access. With a workforce of close to 3,500 spread across Ireland, United Kingdom, the Netherlands, the Nordics, Germany and the USA, Uniphar is a trusted global partner to Pharma and MedTech manufacturers, working to improve patient access to medicines and treatments around the world. Culture at Uniphar We pride ourselves in being truly entrepreneurial, innovative, collaborative, with a strong problem-solving ethos. We have built working relationships which span decades with many of the world’s largest Pharma and MedTech companies. We believe that this is because we know how to build a relationship of trust with our partners - we put our customers and their patients at the heart of what we do and treat them with integrity and respect. Everything Uniphar does is enabled by our people. As we continue to grow domestically and internationally, we become more diverse. This rich diversity fuels our business and enriches our culture. MAIN DUTIES & RESPONSIBILITIES

• Maintenance and continuous improvement of a quality management system in the Uniphar Dublin facility to ensure compliance with the requirement of Good Distribution Practice, ISO 9001 and regulatory requirements
• Manage all deviations, CAPA’s and risk assessments and complete within relevant deadline
• Oversee the uploading of all imported EMP’s to the HPRA
• Responsible for the controlled drug applications and endorsements
• Manage all reported ADE’s, SAE’s and quality defects
• Liaise with the Group Quality department and the HPRA in managing all relevant product recalls
• Ensure all documentation is updated if process changes are implemented within the department
• Liaise with the Quality department on all audits conducted by Uniphar or the HPRA
• Ensure all EMPs are setup as per Uniphar procedures
• Inspect all EMPs received into the Uniphar warehouse
• Management of MAP activities within Pharmasource/Ostomysource
• Attend Quality Team meetings
• Work with departmental managers to ensure quality of processes and procedures
• Liaise with principals and the regulatory authorities during site inspections and audits

About Us

Our Work Experience is the combination of everything that's unique about us: our culture, our core values, our company meetings, our commitment to sustainability, our recognition programs, but most importantly, it's our people. Our employees are self-disciplined, hard working, curious, trustworthy, humble, and truthful. They make choices according to what is best for the team, they live for opportunities to collaborate and make a difference, and they make us the #1 Top Workplace in the area. #J-18808-Ljbffr