Computer Systems Validation Consultant

Job Description

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

Requirements

• 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