Senior Validation Lead - CSV & GxP Expert (Remote)

Dotmatics Ltd.; United Kingdom; À distance; GBP 70 000 - 100 000; Plein temps

Résumé du poste

Dotmatics is seeking a Validation Lead to drive validation activities for the Luma platform and internal systems, ensuring compliance with GxP requirements, 21 CFR Part 11, EU Annex 11, and ISO standards. You will partner with Product, Engineering, and Quality Management to embed validated processes across the SDLC in a remote-friendly environment.

Lead the creation and approval of validation documents, supervise IQ/OQ/PQ execution, and mentor junior staff.

Qualifications

• Deep working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and GxP requirements for software systems.
• Familiarity with ISO 9001 Quality Management System principles.
• Experience authoring/executing IQ/OQ/PQ protocols, traceability matrices, and validation reports; using automated testing tools.

Responsabilités

• Author, review, and approve validation lifecycle docs (Validation Master Plans, URS, FRS, Traceability Matrix, Risk Assessments, IQ/OQ/PQ)
• Collaborate with software quality and devops to leverage automated tools to develop and run protocols
• Apply GAMP 5 framework to determine validation strategies and documentation requirements
• Mentor junior validation staff on methodologies and documentation best practices
• Provide validation guidance to engineers, QA analysts, and project managers on CSV principles and 21 CFR Part 11 controls
• Support customer-facing validation activities, coordinate testing and defect resolution, assist CAPA investigations and audit responses

Connaissances

GAMP 5 knowledge

21 CFR Part 11

EU Annex 11

GxP software validation

SDLC & Agile

Formation

Bachelor's degree in CS/Engineering/Biology or related (preferred)

Outils

Cypress

Playwright

Description du poste

Dotmatics is seeking a Validation Lead to drive validation activities for the Luma platform and internal systems, ensuring compliance with GxP requirements, 21 CFR Part 11, EU Annex 11, and ISO standards. You will partner with Product, Engineering, and Quality Management to embed validated processes across the SDLC in a remote-friendly environment.

Lead the creation and approval of validation documents, supervise IQ/OQ/PQ execution, and mentor junior staff.