6 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 »

English (ideally with business French). Nice to Haves Data Protection Officer certification. Knowledge of regulatory requirements specific to the pharmaceutical industry (e.g., FDA 21 CFR Part 11). Experience with Agile or Scrum Methodologies. Proficiency in Electronic Document Management Systems (EDMS) and other quality management more »

Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products. • Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred. • Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred. more »

ability to analyse and chart data in Excel is essential. Experience with Computerized Systems Validation and knowledge of ISPE's GAMP and FDA 21CFR Part 11 would be advantageous. Adherence to SOPs and experience with a QMS will be required. The ideal candidate will have a life-science more »

using industry-standard software lifecycle management tools such as Jira, Confluence, and AHA! Previous exposure to applying industry compliance and quality standards (GLP, GMP, 21CFRPart11) in software products. Effective communication and stakeholder management skills to facilitate seamless collaboration and alignment across diverse stakeholders. If you possess a passion for driving … innovation in the biopharma sector and are equipped with the requisite skills and experience, we encourage you to apply and be a part of our transformative journey. 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 »