10 of 10 Remote/Hybrid 21 CFR Part 11 Jobs in England

organisation needs. You will work as a direct partner to our engineering teams and alongside our dedicated Regulatory Affairs leadership. Regulatory is not part of this role, but a function you will collaborate closely with. At CoMind, all team members work at least 4 days per week from … Leadership: Lead and develop our existing Quality team, instilling and maintaining a high performance culture. Ensure the CoMind QMS complies with the FDA QMSR (21 CFR Part 820, harmonised with ISO 13485) and 21 CFR Part 11 for electronic records and signatures, while ...

appropriately assessed, documented, approved and validated. Interpret and apply regulatory requirements relating to Computer System Validation, Data Integrity, Electronic Records and Electronic Signatures, including 21 CFR Part 11. Support regulatory inspections, third-party inspections and internal audits while ensuring systems and documentation remain inspection-ready. The skills … Quality, Computer System Validation (CSV), or a related pharmaceutical quality role. Advanced knowledge of Computer System Validation, Software Development Lifecycle (SDLC), Global GxP regulations, 21 CFR Part 11, Electronic Records and Signatures, Data Integrity requirements, and Quality Management Systems. Practical experience reviewing the complete validation lifecycle ...

Experience working with validated systems and understanding of Computerised System Validation (CSV)/Computer Software Assurance (CSA) . Strong knowledge of EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and ALCOA+/data integrity principles . Understanding of OT cybersecurity principles and frameworks ...

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/ ...

routing fundamentals Experience working within a GxP-regulated environment (Pharma, Biotech, Life Sciences) Hands-on experience with: GxP documentation and compliance processes Data Integrity - 21 CFR Part 11/Annex 1 System validation and lifecycle management Good understanding of SDLC within regulated environments Experience supporting ...

About NTT DATA Business Solutions: NTT DATA Business Solutions Group is part of the NTT DATA Corporate Group a top 10 global IT services provider, headquartered in Tokyo, operating in more than 50 countries. We combine a global reach with local intimacy to provide premier professional SAP services from … approach in fast-paced delivery environments. Particularly valuable experience The following experience would be highly beneficial: Pharmaceutical, life sciences or healthcare programme delivery. GxP, 21 CFR Part 11 and regulated validation environments. Computer System Validation (CSV), equipment validation and IQ/OQ/PQ approaches. Performance ...

including MES (Manufacturing Execution Systems), ERP, SCADA, and IoT devices. Ensure IT compliance with manufacturing industry regulations (e.g. ISO 9001, GAMP 5, ISO 27001, 21 CFR Part 11) and data integrity guidelines. Lead root cause analysis (RCA) and CAPA for IT system outages, data synchronization failures ...

Benchling preferable) or comparable laboratory informatics platform, including schemas, modules and custom workflows. Understanding of regulatory standards including GxP, ALCOA+ principles, and 21 CFR Part 11 requirements. Desirable: Knowledge and understanding of the cell and gene therapy industry. Experience designing and implementing system integrations using APIs ...

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 ...