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Computer Systems Validation Consultant
Posted 19 hours 30 minutes ago by Jobtailor
Permanent
Full Time
Other
Cork, Cork, Ireland
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
- 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
Jobtailor
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