1 to 3 of 3 Permanent 21 CFR Part 11 Jobs

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 »

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 »

of raw materials, in process, bulk drug substance, final products andstability products to GMP and in accordance with Annex 11 Computerised Systems and 21CFRpart11 Good Documentation Practices for Electronic Data. Perform stability study programme activities, storage of in process, and final products samples and retention sample management System owners more »