Regulatory Compliance Specialist
4 days ago
Uniphar Group is a dynamic and forward-thinking diversified healthcare services business with a significant presence in Ireland and a growing footprint globally. We deliver high-quality, tailored solutions to our clients, leveraging our extensive experience and cutting-edge technology to strengthen relationships with key pharmaco-medical manufacturers.
Our organisation is structured into three distinct divisions: Supply Chain & Retail, Commercial & Clinical (Med Tech / Pharma) and Product Access. With a talented workforce of over 3,500 professionals spanning Ireland, the UK, Netherlands, Nordics, Germany and the USA, we provide unparalleled service to Pharma and MedTech manufacturers, enhancing patient access to essential medicines and treatments worldwide.
Culture at UnipharWe value innovation, collaboration and problem-solving, embracing an entrepreneurial spirit that drives our growth and success. By fostering trust and respect with our partners, we create lasting relationships that fuel our business and enrich our diverse culture.
ObjectiveThis role will be instrumental in upholding regulatory compliance within the Uniphar Group Businesses, ensuring seamless adherence to GxP requirements and ISO 9001 2015 standards. The successful candidate will possess a meticulous approach to regulatory compliance, effectively implementing deviation management, quality risk assessment, and change control processes.
Main Duties & Responsibilities- Support the quality team in maintaining the Electronic Quality Management System across Uniphar Businesses and achieving KPI targets.
- Collaborate with the quality team to manage deviations, CAPAs, risk management, and change control.
- Contribute to preparing for Regulatory and Client Audits, including educating business units on quality and compliance matters.
- Ensure the timely renewal of Licenses, including Manufacturing licenses and Wholesale Distribution Authorisation.
- Actively identify potential compliance issues and engage in complex tasks.
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