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. Supply Chain & Retail Supply Chain Services provides both pre-wholesale and wholesale distribution of pharmaceutical, healthcare and animal health products to pharmacies and hospital nationwide. The business supports a diverse customer base through the provision of strong service levels coupled with innovative commercial initiatives. In addition, the business provides services and supports that help independent community pharmacy to compete more effectively in an increasingly difficult environment and runs a network of Uniphar-owned pharmacies under the Life, Allcare, McCauleys and Hickeys symbol brands. Pharma – On Demand The On-Demand business is a specialist medical supply business that sources and distributes pharmaceuticals, medical equipment, and consumable supplies to healthcare professionals in over 160 countries worldwide. We have offices in Ireland, UK, Europe, USA and New Zealand. The company’s main divisions encompass everything from International Sales through Sales to NGO’s and Charities, Clinical Trials Supply, Imported (Unlicensed Medicines), Sexual Health Supplies, and the storage and distribution of medical products and devices for third parties. Click here to find out more: About Us - Who we are | Uniphar 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 unpin 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. Finally, Trust is at the heart of how we operate. Everything Uniphar does is enabled by our people and as we continue to grow domestically and internationally, we become more diverse. This diversity fuels our business and culture. 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. The role To support the commercial project workstreams across the areas of sales, commercial, procurement and planning. This role will allow a commercial business executive to join a business wide project in a key business transformation programme. Key Outcomes And Responsibilities Provide independent quality oversight during the implementation and maintenance of computerised system lifecycle throughout Uniphar globally to ensure compliance with regulatory, customer and other relevant standards as applicable. Provide pragmatic, risk-based guidance of CSV approach for new and existing GxP systems. Act as an integral project team member for GxP system projects, responsible for supporting CSV implementation plans for the delivery of new applications across Uniphar globally as directed by line management. Provide guidance to the business to ensure GxP systems are appropriately validated to provide assurance of efficiency, regulatory compliance and ultimately patient safety. Provide guidance and support the business to ensure existing GxP system validation is maintained throughout their operational state, for example, supporting change management and periodic reviews. Support the delivery of a global CSV plan in collaboration with Business, Technology and Quality teams. Support the Global Quality CSV Lead working with existing group companies and new acquisitions to implement local global solutions and to integrate their existing systems into the global platform. Operate within global policies and procedures for CSV and support local entities with the adoption of these operations and creation of deliverables such as risk assessments, SOPs and other regulatory documentation in alignment with the global process. Engage, direct and support colleagues to participate in the global CSV process. Collaborate with the Global Quality CSV Lead to assess and continually improve the global CSV process and plan. Work with cross functional IT teams to ensure all IT systems and processes are documented. Train the business and communicate the importance of the CSV requirements. Support CSV vendor, internal and customer audits as required. Promote a culture of quality excellence that encourages ethical conduct and commitment to compliance. This role will involve significant international interaction and some international travel Key Skills & Experiences CSV subject matter expert, with at least 2 years’ experience in this field Familiar with the requirements of EudraLex Vol 4 Annex 11 and FDA 21 CFR Part 11 Understanding of data integrity, familiar with MHRA GxP Data Integrity Guidance Practical experience of the application of risk-based CSV methodologies such as GAMP5 and CSA in Pharma/medical device industry. Hands on experience in developing and producing CSV deliverables in a GxP environment. High level of IT fluency, able to understand complex systems, architecture and connectivity. Ability to communicate internally at all levels, able to translate between Business, Quality and Technical teams to ensure robust understanding and compliance. Regulatory, customer and commercial focus, able to ensure requirements of all parties are understood and delivered. Effective written communicator, able to deliver concise documentation and adapt writing style to audience as appropriate. Completion of recognised CSV training Experience in multiple regulatory and operational jurisdictions Experience with CSV for Microsoft Dynamics solutions, DMS/QMS and ERPs How We’d Like To Work Together Due to the expected key outcomes associated with this role by its nature it will be a role based out of one of our headquarters in Dublin, Ireland. There will be an element of hybrid working available. It is important to note that we do not expect this job to be a ‘9 to 5’ type position. In return for your flexibility, you will be joining an environment that understands how inter-twined work and life have become - and both the benefits and challenges that brings - and therefore offers a flexible, progressive way of supporting it. If you believe that you meet most of the criteria above, we encourage you to apply. We are an equal opportunities employer and will ensure any reasonable accommodations are implemented as part of the recruitment and selection process.