9 of 9 Remote/Hybrid 21 CFR Part 11 Jobs in the UK

equipment and process validation.Understanding of production equipment controlled by PLCs within manufacturing environments.Strong knowledge of GxP regulations, industry standards, and best practices, including 21 CFR Part 820, 21 CFR Part 11, EU Annex 11, and GAMP.Demonstrated experience managing complex validation projects ...

equipment and process validation.Understanding of production equipment controlled by PLCs within manufacturing environments.Strong knowledge of GxP regulations, industry standards, and best practices, including 21 CFR Part 820, 21 CFR Part 11, EU Annex 11, and GAMP.Demonstrated experience managing complex validation projects ...

driven platform to help advance the treatment of neurological disorders and reduce the uncertainties associated with drug discovery, development and monitoring. As a key part of the global neurological disease research community, the Company has built a global reputation and 20-year track record … software development and validation policies and procedures, ensuring best practice for ‘security & privacy by design’ principles and in compliance with current GCP, FDA 21 CFR Part 11, EU Annex 11, GAMP, FDA QSR Part 820 (QMSR), EU MDR (Regulation 2017/ ...

connect process development to manufacturing, enabling faster, 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 ...

Serbia, Romania or Poland and can be fully home based in any of those countries.As the Senior Business Analyst you will work as part of our IT Business Engagement & Enablement department and partner closely with business and technical stakeholders to uncover the true needs of the organization and translate … Biotech industry domain experience is desirable.A solid grounding in Business Analysis best practices and consulting behaviors.Familiarity with Computer System Validation (CSV), SDLC methodologies, and 21 CFR Part 11 concepts.Experience working within regulated environments such as pharmaceutical, biotech, or CRO organizations.Experience supporting project delivery within established Project ...

technical stakeholders. A practical, commercially aware and solutions‐focused approach. Experience with LIMS, ELN platforms, laboratory systems, GxP, MHRA guidance or FDA 21 CFR Part 11 would be particularly valuable. What’s next? If you are an experienced IT leader who enjoys combining strategy with hands ...

years of experience in Risk Based Quality ManagementRobust understanding of the drug development process and clinical trial executionKnowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP)Experience in risk management, sponsor audits and health authority inspections, root cause analyses … addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally ...

diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel … hosting, security, etc.) in enabling on-premise and cloud IT solutions. Knowledge of data integrity and compliance standards within a GxP-regulated environment (e.g., 21 CFR Part 11). Solution architecture certifications for Microsoft Azure or Google Cloud Platform. Experience working in a product operating model ...

several of the following areas: Security leadership, governance, risk and compliance (GRC) Cloud security architecture and security strategy ISO 27001, GDPR, SOC 2, GxP, 21 CFR Part 11 or similar regulated frameworks Audit leadership, customer assurance and certification programs Healthcare technology, pharmaceutical, biotechnology or regulated SaaS ...