OT Architect - OutsideIR35
- Hiring Organisation
- GCS
- Location
- North Yorkshire, United Kingdom
- Employment Type
- Contract
- Contract Rate
- £450/day Remote, OutsideIR35
controls . Ensure architectural decisions support GMP, GxP, data integrity, patient safety, product quality and inspection readiness . Partner with Engineering, Automation, Manufacturing, Quality, Validation, Cybersecurity, Infrastructure, Data, Applications and senior site stakeholders. Support CSV/CSA, validation, risk assessments, design reviews, change control and regulated technology implementation . Lead … APIs, middleware, event-driven architecture, ETL/ELT and historian integrations . Experience working with validated systems and understanding of Computerised System Validation (CSV)/Computer Software Assurance (CSA) . Strong knowledge of EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and ALCOA+/data integrity principles . ...