The Apprentice participates in and executes the entry level department functions (Designation of Apprentice) in accordance with Fortrea and/or sponsor Standard Operating Procedures (SOPs)
Document Management and Organization
Metrix on IT Quality
Questionnaires and information requests
Review and update of regulated system inventory
Other duties as assigned
Education / Qualifications / Skills:
General knowledge of computer systems infrastructure, development, support and security
Nice to have knowledge of regulations on computerized systems in clinical trials
Education: Bachelor s degree or equivalent in a field related to computer science or Life sciences.
Skills
Computer System Validation
FDA 21 CFR Part 11, Electronic Records and Electronic Signatures; Final Rule (Part 11)
MHRA "GxP Data Integrity Guidance and Definitions (MHRA)
EudraLex Volume 4 Annex 11, The Rules Governing Medicinal Products in the European Union Computerised Systems (Annex 11)
ISO27001, National Institute of Standards and Technology (NIST)