Computer Systems Validation - Consultant

Deloitte

  • Limerick
  • Permanent
  • Full-time
  • 6 days ago
Deloitte is the biggest professional services Firm in the world making an impact is more than just what we do: it’s why we’re here. We’re driven to create positive progress for our clients, community, people, and the planet. This sense of purpose inspires us to work to the highest standards, to tackle the challenges that matter.Audit & Assurance is one of our biggest service lines and the driving engine of Deloitte Ireland. We provide services that go beyond expectations to deliver insight and confidence for our leading international and local clients.Our Audit and Assurance teams are a key part of the financial reporting ecosystem. Deloitte is constantly evolving its audit and assurance processes providing value and insights. We leverage cutting-edge technology in combination with our global network of professionals applying diverse skills and experiences to make an impact that matters to our clients..About the role
  • CSV / Validation projects for clients in compliance with various industry regulations
  • Reviewing CSV deliverables and advising clients in CSV best practice
  • Completing validation activities to client requirements
  • Supporting client in risk based approach and 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 compliance and industry best practices
About you
  • Software, IT, Pharma or Science degree
  • Proven experience in IT related field; experience in systems such as JIRA, GxP computerized system applications, LIMS, Trackwise, Veeva Vault, Bug tracking tools
  • A flair for technology and computing;
  • CSV experience is preferable but not essential; experience can include writing, reviewing and executing CSV documentation
  • 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
  • Proficiency with MS Office Tools
If you believe that you meet most of the criteria above, we advise you to apply. Deloitte is an equal opportunities employer and will ensure any reasonable accommodations are implemented as part of the recruitment and selection process.​What we offerYour reward at Deloitte is competitive, supports our purpose and enables our people to never stop growing. Your reward at Deloitte is not just your salary, we believe in investing in our people's personal and professional development and empowering their work-life balance. Our ambition is to achieve gender equality and enable continuous growth. We offer supports and benefits that suit you, wherever you are in life, including health and well-being, pension, savings, training, coaching and among others.Keep on being you. Bring your full, absolute self to work, every day. Explore, question and collaborate. Stretch your thinking, while building a career that inspires and energises you. And, whatever motivates you, keep growing both professionally and personally – because when you make an impact that matters, we do too.

Deloitte