CSV Validation Specialist — Regulated Systems, Hybrid

Deloitte Digital; Cork; Hybrid; 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

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