7 of 7 21 CFR Part 11 Jobs in the UK

In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. The role: The role of a Laboratory Systems Specialist is to lead the development and implementation of robust Lab/digital infrastructure within our R&D laboratories for … network connectivity (e.g., OPC-UA, MQTT, REST APIs, TCP/IP) and data pipelines from edge devices to cloud/on-premise environments. Support system validation efforts (e.g., CSV, 21 CFR Part 11 compliance) in partnership with QA and IT Compliance teams, while also providing technical troubleshooting and support for instrument connectivity and data integration issues. … UA, MQTT, REST/SOAP APIs, SQL, Python, etc. Familiarity with lab automation platforms (e.g., Tecan, Hamilton, Agilent, Beckman, Sartorius) and related data workflows. A good understanding of GxP, 21 CFR Part 11, data integrity principles, and validated environments is a plus. Every day, Lonza's products and services have a positive impact on millions of More ❯

software products. You'll be responsible for aligning information security and data protection with our mission to deliver FDA-regulated digital therapeutics. This includes leading regulatory security compliance (HIPAA, 21 CFR Part 11, FDA SaMD guidelines), proactively managing risk, and collaborating across engineering, product, compliance, and leadership teams. Location NYC, London, Ramat-Gan This role is … the opportunity to collaborate closely with our dynamic team in person. Responsibilities Design, implement, and lead Remepy's security practice and enterprise cybersecurity program Own security compliance with HIPAA, 21 CFR Part 11, FDA pre/postmarket cybersecurity guidance, and related frameworks Collaborate with Product, Engineering, and Compliance to embed security-by-design across our software More ❯

Vault migration (Quality, Regulatory, Clinical, or Commercial). Hands-on knowledge of Veeva Vault Loader, APIs, or other ETL tools (e.g. Boomi, Informatica, Talend). Strong understanding of GxP, 21 CFR Part 11, Annex 11, and cloud system validation. Excellent stakeholder and vendor management skills. Confident working with complex datasets and metadata. Fluent in English More ❯

date knowledge with current and proposed pharmaceutical regulations. Essential Skills and experience: Experience working in QA/IT/IS on a pharmaceutical manufacturing site with working knowledge of 21 CFR Part 11, EudraLex volume 4 Annex 11 and Good automated manufacturing practice (GAMP). Very good communication skills and demonstratable experience of working as … part of cross functional teams. Experienced in working with cross functional teams to identify and implement changes and improvements within pharmaceutical manufacturing and warehousing environments. Must have excellent communication, influencing and troubleshooting skills. Ability to effectively contribute within a team environment and work on own initiative. Meticulous attention to detail. Excellent planning and organisational skills. Ability to work accurately More ❯

teams, including OT, IT, data engineering, and business stakeholders, to ensure successful implementation of smart factory and digital transformation initiatives. Ensure all solutions comply with relevant regulatory standards (e.g., 21 CFR Part 11, GAMP 5) and industry best practices. Client Engagement & Advisory: Act as a trusted advisor to clients, translating business challenges into actionable technical solutions. More ❯

teams, including OT, IT, data engineering, and business stakeholders, to ensure successful implementation of smart factory and digital transformation initiatives. Ensure all solutions comply with relevant regulatory standards (e.g., 21 CFR Part 11, GAMP 5) and industry best practices. Client Engagement & Advisory: Act as a trusted advisor to clients, translating business challenges into actionable technical solutions. More ❯

inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a dynamic, ambitious team. You will play a critical part in driving innovatio and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth. Activities Design, develop, and maintain … based solutions tailored to pharmaceutical R&D and business needs Customize SharePoint sites and workflows to support document management, collaboration, and compliance Ensure alignment with regulatory standards (e.g. GxP, 21 CFR Part 11) and internal quality procedures Collaborate with IT, Quality, and R&D teams to translate functional requirements into scalable SharePoint solutions Develop and maintain More ❯