Quality Specialist

Overview

Join to apply for the Quality Specialist role at Uniphar Group.

The Role

The role will support the Uniphar Durbin Ireland in the 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 compliance and play a key role in maintaining compliance with GDP. The incumbent will also act as the DRP on the Uniphar Durbin Ireland WDA.

Responsibilities

• Support the maintenance of the Electronic Quality Management System across the Uniphar Businesses and support the quality team in achieving KPI targets
• Assist in preparation for Regulatory Audits
• Provide quality and compliance support during client audits, ensuring readiness and successful outcomes
• Management of the quality mailbox, vendor, and product creations along with planning and implementation of the annual bona and monthly fide process and checks
• Act as a subject matter expert for deviations, CAPAs and change management
• Assist with the integration of QMS into Durbin Ireland Business
• Assist with the compilation and analysis of data associated with the performance of the Quality System (e.g., Management Reviews)
• Support maintenance of 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
• Works with Business unit leads to develop SOPs and WI for the day-to-day management of the business
• Willingly accepts challenging assignments
• Demonstrates a strong interest in progressing towards the role of Deputy Responsible Person (RP)

Employment Details

• Location: Greenogue
• Employment type: Full-time
• Work arrangement: Hybrid

Qualifications, Experience & Skills Required

• A third-level qualification in Pharmacy/ Science preferred
• Experience in medicines management, good distribution practice, or regulatory affairs
• Understanding of regulatory compliance in GDP, GMP, GCP, and GVP
• Experience of HPRA inspections
• Excellent PC skills, including Word & Excel PowerPoint etc.
• Strong analytical skills

Competencies

• Process Improvement Mentality
• Self-starter
• Demonstrates initiative
• Excellent Communication skills, both written and spoken
• Ability to learn and adapt quickly to changing priorities
• Attention to detail
• Team player
• Track record in generating high energy and engagement levels

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.

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 underpin 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.
• Trust is at the heart of how we operate.

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.

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