Description
The Computer Systems Validation Specialist will apply GAMP 5 and the validation lifecycle to validate computer systems and processes in regulated life sciences environments. The role requires knowledge of 21 CFR Part 11, Annex 11, EU GMP, and applicable ANVISA resolutions, along with risk management, change control, deviation management, CAPA, quality management, and documentation tools. Candidates should have an undergraduate degree in a relevant engineering, pharmacy, biological sciences, computer science, or information systems field, intermediate-to-advanced English, and experience in computer system validation or regulated-environment validation; postgraduate study in quality, validation, regulatory, or information systems management is preferred.
