Description
CAI is hiring a full-time Computer System Validation Specialist in Sydney, Australia, to lead IQ/OQ/PQ validation activities for GxP-regulated systems in an advanced therapeutics facility. The role involves validating ERP, LIMS, QMS, and equipment-related software; ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5; authoring validation plans, risk assessments, and traceability matrices; supporting data integrity and audits; and training staff. Candidates need at least three years of CSV experience in pharma, biotech, or medical devices, strong GAMP 5 and data integrity knowledge, and Australia/New Zealand permanent residency or citizenship.
