Quality Compliance Specialist (LDR)

Quality Compliance Specialist (LDR)

12 month Fixed Term Contract

Full time, CityWest

The Role

We are currently looking for a Quality Specialist (Compliance) to look after the maintenance and continuous improvement of a quality management system in the Uniphar Dublin Citywest facility. To ensure compliance with the requirement of Good Distribution Practice, ISO 9001, regulatory and Principal requirements.

Ensuring the effective implementation of a quality management system in the Uniphar Group.

Responsibilities include:

• •Documentation: Procedure writing and review
• •Documentation: Implementation of new procedures and policies
• •Training: Assisting with GDP and procedural based training
• •Management of Deviation and CAPA’s within the Quality Management System
• •Management of Change Control’s within the Quality Management System
• •Management of Risk Assessments and carrying out risk assessments
• •Investigation of Complaint Handling
• •Auditing: Assisting and participating with both regulatory and supplier audits
• •CD Applications and Reconciliations
• •Assisting the RP/DRP with the process of returns
• •Reporting of Exempt Medicinal Products to HPRA
• •Assisting with Recalls process
• •Customer/Vendor/Product Setup approvals
• •Bona Fides: Assisting with carrying out checks on both customers and suppliers
• •Participation in other projects/duties as defined by the Quality Lead/Quality Compliance Manager/Head

Skills & Experience

• •Experience working within GDP-compliant pharmaceutical, healthcare, or wholesale distribution environments.
• •Proven ability to develop, review, and implement SOPs, policies and quality documentation.
• •Experience supporting internal, supplier, and regulatory audits.
• •Skilled in complaint investigations, returns, product recalls, risk assessments and root cause analysis.
• •Familiarity with bona fide checks, and customer/vendor/product set up requirements.
• •Experience delivering or supporting GDP and procedural training.
• •Knowledge of HPRA regulatory requirements.
• •Strong organisational, communication, and stakeholder management skills.
• •Proficient in Microsoft Office and electronic quality management systems.

Core Competencies

• •Positive can-do attitude with a focus on action.
• •Pursues a standard of excellence, relentlessly measuring and chasing to ensure targets are met.
• •An ability to prioritise and work efficiently to meet deadlines.
• •Excellent communication skills.

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.