8 of 8 Permanent 21 CFR Part 11 Jobs in London

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 ...

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 ...

external sponsors with regard to statistical programming tasks.Represent Parexel at sponsor marketing and technical meetings.Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).More about you...On your first day we'll expect you to have:University degree.Strong written … understanding of the programming and reporting process.Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.Ability to learn new systems and function in an evolving technical environment.Strong project management skills.Strong organizational skills, ability to manage competing ...

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/ ...

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 ...

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 ...

across healthcare, medical devices, laboratory supplies, and biotech distribution. You will translate commercetools’ modular flexibility into trust-building messaging that addresses regulatory compliance (FDA 21 CFR Part 11, GxP,MDR), audit trail requirements, data security, and complex healthcare procurement processes. Vertical Positioning & Messaging: Develop and execute … designed to let your talent shine. We proudly welcome applicants of every race, color, religion, gender identity, sexual orientation, age, and any other part of your identity that makes you who you are. As an equal opportunity employer, we believe that our strength lies in our diversity ...

mapping and gap assessments, and supporting the rollout of new or enhanced systems aligned to global regulatory standards (including GMP, GDP, GCP, GLP, FDA 21 CFR 210/211, EU GMP/EudraLex, ICH Q7/Q10).Authoring, reviewing and maintaining quality policies, standards, SOPs, forms and controlled ...