Computer Systems Validation - Consultant

Deloitte Digital; Cork; On-site; EUR 36,000 - 65,000; Full time

Benefits offered by this job

Health & wellness

Learning & development

Pension scheme

Flexible working

Job summary

Deloitte Digital in Ireland seeks a CSV Compliance Specialist to perform CSV/validation projects for clients, review deliverables, and advise on CSV best practices. You will complete validation activities to client requirements and support risk-based approaches and process improvements.

Based in Cork or Limerick with a flexible hybrid model, you may visit client sites as needed. Deloitte offers a competitive salary and a broad benefits package, ongoing learning, pension schemes, and flexible

Qualifications

• 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

Responsibilities

• 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

Skills

Science/Software degree

Tech savvy

SDLC knowledge

CSV experience

Education

Science/IT/Pharma degree

Tools

JIRA

GxP systems

LIMS

Trackwise

Veeva Vault

Bug tracking tools

Job description

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.

Equal Opportunities

Deloitte is an equal opportunities employer and will ensure that any reasonable accommodations are implemented throughout the recruitment and selection process.