1 to 3 of 3 21 CFR Part 11 Jobs in England

develop technology solutions deployed in clinical trials - such as CTMS or other relevant technologies Familiarity with navigating the clinical trial lifecycle and adhering to 21-CFR Part 11 regulations and validation processes Well-versed in the utilisation of common tools and technologies within clinical trials, including … Keywords: clinical, data, management, manager, quality, systems, process, compliance, controls, tools, CSV, validation, regulatory, compliance, computer, systems, SDTM, ADAM, CDISC, SAS, Snowflake, QA, audit, 21-CFR Part 11, Director, VP, drug, development, R&D, discovery, IT, pharmaceutical, biotech, operations more »

Integrity and Regulatory Standards : Thorough knowledge of data integrity principles, Electronic Records and Electronic Signatures (ERES) requirements, and relevant international regulations, such as Annex 11, 21 CFR Part 11, and Good Automated Manufacturing Practice (GAMP 5). Experience with Relevant Software Packages : Familiarity and hands more »

and laboratory workflows in various domains (e.g., pharmaceutical, biotechnology, manufacturing). Knowledge of regulatory requirements and compliance standards relevant to laboratory operations (e.g., FDA 21 CFR Part 11, ISO 17025, GLP, GMP). Experience with relational databases Oracle, SQL Server, Postgres. Experience with cloud services and more »