Computer Systems Validation - Consultant

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.

What are the main activities and tasks involved?

• 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

What skills and qualifications do I need?

• 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

Where will I be working and what is the working model?

This role is based in our Cork or Limerick offices with a flexible hybrid working model that supports a blend of office and remote working. Client site visits may be required depending on project needs. For more information, please visit our Deloitte Works webpage.

What benefits and supports are available to employees? 

Deloitte offers a comprehensive benefits package including competitive salary, health and wellness programmes, continuous learning and development, pension schemes, and flexible working arrangements. We are committed to supporting your wellbeing and career growth. For more information, please review our Rewards & Benefits webpage.

If you meet most of the criteria above, we encourage you to apply. Deloitte is an equal opportunities employer and will ensure that any reasonable accommodations are implemented throughout the recruitment and selection process.

What we offer

Your reward at Deloitte is competitive, purpose driven and designed to support your growth. It is more than salary. We invest in your personal and professional development, empower your work life balance and offer benefits that support you at every stage of life. These include health and wellbeing supports, pension and savings options, training and coaching and enhanced leave options.