3 of 3 Permanent 21 CFR Part 11 Jobs in the Thames Valley

party integration developments, and emerging customer expectations around connectivity, data management, and regulatory compliance Partner with Strategic Segment Managers to understand how regulatory requirements (21 CFR Part 11, GAAMP, OECD GLP) affect software product needs in priority end markets Translate hardware NPI requirements into software specification … relevant scientific discipline — providing credibility with scientific end users and technically specialist R&D teams Experience with regulatory software requirements in analytical instrument markets: 21 CFR Part 11, GAAMP, GLP/GMP compliance, or equivalent Familiarity with laboratory informatics ecosystem: LIMS, ELN, data management platforms ...

machine controls .Experience with machine vision and automated inspection systems .Knowledge of serialization and aggregation requirements and associated Level 1–4 packaging architecture.Familiarity with 21 CFR Part 11, electronic records/electronic signatures, dataintegrity, and computerized system lifecycle principlesUnderstanding of packaging-related quality considerations such … introduction, technology transfer, scale-up, and commercial manufacturing readiness.Ability to quickly learn new equipment, technologies, and manufacturing processes.A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative , consistent with the language in the existing role.As part ...

technologies.* Strong software engineering and development experience including software development, issue management, DevSecOps, continuous integration, or cloud deployment.* Experience with software development for 21 CFR Part 11-compliant or regulated environments would be advantageous. **Soft skills:*** Proven leadership, strong communication and interpersonal skills. **Additional Details**This ...