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

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

Computer Systems Validation Consultant

Key skills