13 of 13 Remote 21 CFR Part 11 Jobs

role in delivering high-impact validation projects, with a focus on ERP systems and other critical computerized systems in regulated environments. You will be part of innovative projects, ensuring compliance, efficiency, and quality across the lifecycle. Key Responsibilities: Lead CSV Projects: Take ownership of ERP and other computerized system … validations (IQ, OQ, PQ), preparing and reviewing critical documentation (VMP, URS, SOPs). Ensure compliance with EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, and Data Integrity guidelines. ERP & System Expertise: Work hands-on with ERPs, eDMS, eQMS, LIMS, laboratory systems, SCADA ...

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/ ...

audit reports Working familiarity with GAMP 5 concepts (software categories, V‐model, risk‐based testing) and key regulations including ICH E6(R3), EU Annex 11, and 21 CFR Part 11 Right to work in the UK without sponsorship Nice to have: Previous experience ...

experience we’re looking for: • Strong pharmaceutical CSV/GxP validation experience • SAP ERP/SAP S/4HANA validation exposure • GAMP 5, 21 CFR Part 11 and EU Annex 11 • Validation Plans, Risk Assessments, URS, RTM, IQ/OQ/PQ and Validation Reports ...

support them in effective line management arrangements for their own teams as applicable.Knowledge, Qualifications, Skills and ExperienceKnowledge & QualificationsEssential:A1 SCQF level 9, 10 or 11 (Ordinary/Honours/post graduate qualification or equivalent plus a broad range of relevant experience at a level appropriate to the responsibilities … expert knowledge of clinical trial technologies, electronic data capture platforms, software application lifecycles and systems integration, including governance requirements for computer systems validation, 21 CFR Part 11 compliance, data security and regulatory compliance within clinical research environments.A5 Extensive and expert knowledge of data controllership, processing ...

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 ...

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 … 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 ...

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 ...

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 ...

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 ...