1 to 25 of 35 21 CFR Part 11 Jobs in the UK

eConsent, and immutable audit trails Regulatory-Grade EDC for GCP Trials: expanding to eCRFs, query management, data lock, CDISC standards (CDASH/SDTM), and 21 CFR Part 11/EU Annex 11 compliance Integrated Trial Platform: full CTMS workflows and decentralized trial capabilities feeding directly … SMART on FHIR, Epic Interconnect) and REDCap import/export so study teams can migrate without manual re-entry Translate CDISC (SDTM/CDASH), 21 CFR Part 11 and EU Annex 11 requirements into clear engineering PRDs (e-signatures, immutable audit logs, query workflows, data ...

platform’s next chapter - a Patient Registry solution, electronic data capture platform, and a validated ePRO library. Ship a regulatory‐grade product, considering e.g. 21 CFR Part 11 audit trails and eConsent with e‐signatures. Treat compliance as a design constraint to engineer around … ePRO/eCOA, eConsent, patient registry, or sensor‐based study platforms. Hands‐on experience shipping under GCP/ICH E6(R3), 21 CFR Part 11, and EU Annex 11, including computer system validation and audit‐ready release management. Working fluency in clinical data standards, especially ...

diligence on company sales and investments. The role You will check whether software used in drug development is validated to GxP standards, as part of technology due diligence for clients who are selling, buying or investing in life sciences technology companies. Pharmaceutical buyers want proof that a platform producing … evidence for platforms that produce clinical trial and real world evidence outputs. Check audit trails, access controls, electronic records and change control against 21 CFR Part 11 and EU GMP Annex 11. Judge whether the validation is proportionate to risk, using GAMP 5 and Computer Software ...

accelerate discovery while protecting data integrity, compliance, and multi-tenant unit economics. This position reports to the Senior Director, Platform Product Management and is part of the Platform Product Team and will be an office based role (based in the UK), however a remote position will be considered … data contracts across ELN, spreadsheet, and inventory data. Govern Compliance, Security & Unit Economics: Ensure permission-aware retrieval and tenant isolation by design (supporting 21 CFR Part 11 and GxP standards) while monitoring token economics, latency, and quota utilization per tenant. Drive Customer Adoption & Validation: Collaborate with ...

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 ...

requirement: Candidate needs to be familiar with the US and International Regulations and Standards governing the development of technical solutions such as GLP, GMP, 21 CFR Part 11, Part 210, Part 211, Part 820 Technical Skills: Operating System familiarity with at least ...

late-stage clinical trials. Its products operate at the intersection of several regulatory regimes, including IVDR, MDR/SaMD, ICH E6 (R3) GCP, 21 CFR Part 11, the EU AI Act, and the emerging FDA and EMA frameworks for AI in drug development. Responsibilities Lean … practice and trials. Working knowledge of computerised system validation in clinical trials, ICH E6 (GCP), GAMP 5, ISO 13485, ISO 14971, IEC 62304 and 21 CFR Part 11. Familiarity with AI-specific quality and risk frameworks: FDA AI/ML SaMD Action Plan and FDA guidance ...

activities through to closure. Desirable Experience Familiarity with Computer Software Assurance (CSA) and risk-based assurance principles. Knowledge of GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11 and relevant data integrity guidance. Experience testing enterprise systems such as MES, ERP, LIMS ...

Computer Science, Information Systems, or related discipline required. Advanced degree or relevant professional certifications desirable. Experience and Skill Requirements Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+, Windows/Active Directory environments, laboratory systems, software lifecycle, periodic review, and supplier ...

Data Integrity Ensure laboratory connectivity and integration solutions meet applicable GxP requirements and organizational quality standards. Apply relevant requirements and principles, including FDA 21 CFR Part 11 and EU GMP Annex 11 where applicable, ALCOA+ data integrity principles, and Good Documentation Practices. Support requirements definition ...

lead is required. Knowledge of US FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GCP regulations, Electronic Records; Electronic Signatures regulation (21 CFR Part 11) and EU Annex 11 is a plus. Education and/or Certification Requirements The candidate must possess … bachelor’s degree in a life science, supply chain management, or information technology field, or equivalent experience. Summary 4G Clinical is honored to be part of Fast Company's 2020 Best Workplaces for Innovators list, citing businesses and organizations that demonstrate a deep commitment to encouraging innovation ...

remotely in the UK, with occasional London meetings, delivering findings for client reports. The role requires deep experience in computerised system validation, GAMP 5, 21 CFR Part 11, EU GMP Annex 11 and CDISC standards, with the ability to produce clear, actionable fixes for potential ...

Custom reports, dashboards and KPIs, using built-in and external tools Interpreting lab data and presenting insights 7. Regulatory and compliance knowledge GxP, FDA 21 CFR Part 11, ISO 17025 and GMP Electronic signatures, audit trails and data validation processes 8. Infrastructure and environment Windows Server ...

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 ...

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, data integrity, and computerized system lifecycle principles. Understanding of packaging‐related quality considerations … 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. Our Working Model ...

continuous improvement. Develop, maintain and improve manufacturing software systems, electronic records, reporting tools and digital workflows in compliance with GMP, FDA, ISO 13485, 21 CFR Part 11 and applicable regulatory requirements. Lead Computer System Validation (CSV) activities, including the development and execution of Validation Plans, Risk … both internal and external agents. Confident and effective decision maker, with a proven leadership ability to negotiate and influence others. Capable of working as part of a multi-disciplined team in an aggressive, dynamic and results motivated environment. Demonstrable analytical & problem-solving skills, a process improvement orientation ...

Anthropic, OpenAI, Hugging Face) for applied use cases Experience in pharmaceutical, life sciences, or highly regulated industry environments Familiarity with validated system environments (GxP, 21 CFR Part 11) is a plus Proficiency in English (written and verbal) at a professional working level ...

orchestration) to increase throughput and eliminate manual transcription and error. Ensure laboratory and clinic systems meet GLP, GCP, GCLP, CLIA/CAP (where applicable), 21 CFR Part 11, and ALCOA+ data integrity expectations, including audit trails, electronic signatures, and instrument qualification. Serve as trusted technology advisor ...

workcell orchestration) to increase throughput and eliminate manual transcription and error.Ensure laboratory and clinic systems meet GLP, GCP, GCLP, CLIA/CAP (where applicable), 21 CFR Part 11, and ALCOA+ data integrity expectations, including audit trails, electronic signatures, and instrument qualification.Serve as trusted technology advisor ...

inside sales, preferably within the pharmaceutical or healthcare software industry. Familiarity with drug safety regulations and compliance requirements, including FDA regulations (e.g., FDA Title 21 CFR Part 11). Strong technical aptitude or familiarity with software systems. Excellent verbal and written communication skills. Customer-centric approach … industry trends and market dynamics. Integrity and ethical conduct consistent with RxLogix Corporation's values and industry standards. Join RxLogix Corporation and be a part of our passionate sales team! Apply now to become our Inside Sales Team Member and contribute to our mission of revolutionizing drug safety. #J ...

quantization, batching, or KV-cache strategy, to improve latency and cost. Experience delivering ML or AI systems in a regulated or validated environment (GxP, 21 CFR Part 11, SOC 2), including computer system validation and audit readiness. Background in scientific, life sciences, or laboratory data domains. ...

software development life cycle Proven prior experience as a business analyst and delivering software products Ability to work with ambiguity Prior experience with 21 CFR Part 11 regulated environment Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa ...

chemical processing or other highly regulated engineering sectors. Knowledge of containment systems, process equipment or specialist manufacturing machinery. Experience with GAMP 5 and FDA 21 CFR Part 11 requirements for computerised systems and validation. Experience working with safety-critical instrumentation and control systems. Familiarity with Factory ...

with Rust, C++, embedded or device-Adjacent software, SDKs or hardware integration. High-integrity systems: Experience or interest in reliability and traceability requirements, including 21 CFR Part 11, GLP, ISO 27001 or ISO 17025. Data and intelligence: Experience with SQL, computer vision, ML techniques, local data … looks like In your first 6-12 months, we would expect you to: Cross-stack impact: Ship meaningful product functionality across more than one part of the software stack. System understanding: Build enough familiarity with the wider product to make sound cross-stack technical decisions. Architecture and practice: Lead ...

Location: LiverpoolSalary: 50,000 - 60,000 (per annum)Job type: PermanentWorking pattern: Full timeIndustry: Engineering/Mechanical EngineeringCompany: HaysConsultant: Alex MellorHays office: Liverpool — Part 2nd Floor, 5 St Paul’s Square,Phone: 01512391296Email: Alex.Mellor@hays.comControl Engineer – NuclearLocation: North West Salary: Competitive, dependent on experience Sector: Nuclear/Industrial Machinery … 18th Edition and relevant BS EN standards.Experience with ATEX, hazardous-area equipment or intrinsically safe circuits would be advantageous.Knowledge of GAMP 5/FDA 21 CFR Part 11 would also be beneficial, particularly for candidates coming from pharmaceutical environments. [Hosokawa.pdf | PDF]The PersonWe're looking ...