Quality Specialist

3 weeks ago

Cork, Cork, Ireland TN Ireland Full time

Social network you want to login/join with:

Quality Specialist & Deputy RP (Annacotty), Cork City

Client: Hickey's Pharmacy

Location: Cork City, Ireland

Job Category: Other

EU work permit required: Yes

Job Reference:

ea7786a716bd

Job Views:

81

Posted:

03.03.2025

Expiry Date:

17.04.2025

Job Description:

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.

Objective
Based in Annacotty, Limerick or can travel to the depots based in Cork, Sligo and Limerick. The role will support the Uniphar Group Businesses in maintenance of the QMS along with the development and implementation of processes and systems to maintain compliance with the GxP requirement and ISO 9001 2015 requirements. The role will require a systematic and thorough approach to achieving regulatory compliance through the processes of deviation management, quality risk assessment, and change management.

Main Duties & Responsibilities

  • Support the maintenance of the Electronic Quality Management System across the Uniphar Businesses and support the quality team in achieving KPI targets.
  • Support the quality team in the management of deviations and CAPAs, risk management, and change control.
  • Additionally, the role will support as Deputy Responsible Person for the required Wholesale distribution authorisation(s).
  • Assist in preparation for Regulatory and Client Audits.
  • Assist with ISO certification process for the Group entities.
  • Assist with the integration of QMS into Uniphar Business Units.
  • Assist with the compilation and analysis of data associated with the performance of the Quality System (e.g. Management Reviews).
  • Support maintenance of Licenses including Manufacturing licenses and Wholesale Distribution Authorisation.
  • 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.
  • Happy to engage in challenging assignments.
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