Leave us your email address and we'll send you all the new jobs according to your preferences.

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
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
Email this Job