Quality Specialist and Deputy RP

Quality Specialist and Deputy RP

Full Time Permanent

Greenogue

The Role

The role will support the Global Access business within Uniphar Durbin Ireland and will ensure the maintenance of the QMS along with the development and implementation of processes and systems to maintain compliance with the GxP requirements 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.

MAIN DUTIES & RESPONSIBILITIES

• Support maintenance of Wholesale Distribution Authorisation.
• Support the maintenance of the Electronic Quality Management System and support the quality team in achieving KPI targets.
• Maintain and update the Quality Management System (QMS) documentation relevant to global distribution.
• Author, review, and approve Standard Operating Procedures (SOPs) and Quality Agreements.
• Conduct quality assessments and audits of third-party logistics providers and CDOs.
• Support the quality-related onboarding of new partners.
• Investigate and lead quality deviation investigations.
• Lead and support CAPA and change control processes.
• Oversee temperature monitoring programs for cold chain and ambient shipments.
• Review and assess temperature excursion reports, ensuring appropriate impact and risk assessments and documentation.
• Support with the management of Quarantine and Recall requests.
• Oversee complaints and Pharmacovigilance events relating to global access supply.
• Assist in preparation for Regulatory Inspections and client audits and ensure readiness.
• Ensure audit findings are addressed and closed in a timely manner.
• Management of vendor, customer and product approvals.
• Assist with the compilation and analysis of data associated with the performance of the Quality System (e.g., Management Reviews).
• Support monthly reporting of metrics associated with the Quality Management System.
• Accountable for completing activities within required timelines.
• Proactively highlight any issues around compliance.
• Willingly accepts challenging assignments.
• Demonstrates a strong interest in progressing towards the role of Deputy Responsible Person (RP).
• Work closely with Supply Chain, Regulatory, Program and Commercial teams to ensure seamless product access.

QUALIFICATION, 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 Background

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. With a workforce of more than 3,000 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 and treatments 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 expert teams. Uniphar is organised into three key divisions: Uniphar Supply Chain & Retail, Uniphar Medtech and Uniphar Pharma

Culture at Uniphar

From our leadership team and across all of our divisions, Uniphar lives and breathes four key culture pillars:

1.We have a People First approach, we do the right thing and take a stand for our people.

2.We foster a strong Entrepreneurial Spirit where Adaptability, Commitment & Resilience is embodied in our way of working.

3.We have a Common Purpose that connects our diversified businesses and people.

4. Finally, Trust is at the heart of how we operate.

Please note that Uniphar is an equal-opportunity employer; we do not discriminate and welcome all responses. 

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