Deloitte is the world’s number one professional services firm and making an impact is more than what we do. It is why we are here. We bring challenge, curiosity and edge to every project, driving positive progress for our clients, our people, our communities and the planet. This purpose inspires us to work to the highest standards and to tackle the challenges that matter. Number one never stops challenging.
Audit and Assurance is one of Deloitte Ireland’s largest service lines and a core engine of our business. As the world’s number one professional services firm, we bring challenge, curiosity and edge to the financial reporting ecosystem. We deliver insight, confidence and value for leading local and international clients.
Our teams combine advanced technology with deep professional expertise to evolve our audit and assurance processes. You will work with talented colleagues across our global network to make an impact that matters every day. Number one never stops challenging and neither do we.
We offer a competitive starting salary of €45,000.00 for this role, with salary adjustments reflecting your experience level and expertise.
. Why you'll enjoy this new opportunity
Deloitte is the world’s number one professional services firm and making an impact is more than what we do. It is why we are here. We bring challenge, curiosity and edge to every project, driving positive progress for our clients, our people, our communities and the planet. This purpose inspires us to work to the highest standards and to tackle the challenges that matter. Number one never stops challenging.
Audit and Assurance is one of Deloitte Ireland’s largest service lines and a core engine of our business. As the world’s number one professional services firm, we bring challenge, curiosity and edge to the Life Sciences sector. We deliver insight, confidence and value for local and international clients. You will work with talented colleagues across our global network to make an impact that matters every day. Number one never stops challenging and neither do we.
Key skills and prior experience that align well with this position
Software, IT, Pharma, Science degree or related discipline
Proven experience in IT related field; experience in systems such as JIRA, Trackwise, Veeva Vault
A flair for technology and computing
Experience of validating computerised systems with AI integration is preferable but not essential
Experience in working in regulated industries preferable; solid understanding of EudraLex Volume 4, including Annex 11, FDA 21 CFR 11 and Good Automation practices (GAMP)
Understanding of SDLC and methodologies such as Agile and Waterfall
Basic understanding of quality management systems and data integrity principles
Experience managing CAPA lifecycle activities, supporting inspection readiness for Food and Drug Administration (FDA) or European Medicines Agency (EMA) audits
Experience applying 21 CFR Part 11, European Union Annex 11, GAMP 5, and data integrity requirements, including ALCOA+ principles
Proficiency with MS Office Tools
What type of work will I be doing?
Prepare and execute, and review validation deliverables for computerised systems in compliance with FDA, EMA, ICH, and other relevant regulations
Advising clients in CSV best practice and regulatory compliance
Completing validation activities to client requirements
Supporting client in risk based approach and identify process improvement opportunities
Providing CSV guidance and support to project teams in the resolution of validation documentation corrections and/or test defects
Proactively monitor systems and processes to ensure compliance with standard operating procedures, audit requirements and industry best practices
Manage validation change control documentation and support CAPA and quality metrics programmes
Apply risk-based validation principles to assess system impact, classify validation requirements, and support compliance with GAMP 5 and data integrity expectations
Drive…