4 of 4 Remote/Hybrid GAMP Jobs in the UK

more reliable tech transfer and batch release. Ensure architecture patterns comply with Life Sciences regulatory frameworks: GxP, 21 CFR Part 11, EU Annex 11, GAMP 5and data integrity requirements. Collaborate with client quality and regulatory affairs teams to embed compliance-by-design principles into solution architectures. Identify and leverage ...

matrix organisation. Desirable Experience supporting Phase III or pivotal clinical studies. Audit and regulatory inspection experience. GMP and CMC quality exposure. Knowledge of CSV, GAMP 5, data integrity, and electronic systems compliance. Experience within biologics, advanced therapies, cell therapy, or gene therapy. What's on Offer Opportunity to shape ...

best practices. Experience collaborating with cross-functional teams across Engineering, Data Science, Product, and Quality. Strong knowledge of QMS, Computer System Validation (CSV), GxP, GAMP 5, ICH-GCP, and 21 CFR Part 11. Familiarity with evolving AI regulations, including the EU AI Act and FDA/EMA guidance on AI. ...

mindset — organized, analytical, and independent. Nice to Have Experience in embedded systems, industrial automation, or OPC UA. Understanding of regulated software traceability (e.g., GxP, GAMP). Tools: Azure DevOps (primary), Polarion (secondary) If you love bridging business goals with technical clarity — and you thrive on creating structure out of complexity ...