1 to 8 of 8 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 »

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 »

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 »

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 »

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 »

Assurance, Computer Systems Validation & Computer Software Assurance. A sound knowledge of IT Security, GDPR & IT Systems & Infrastructure. Experienced with Q-Systems (eg EU: Annex 11/FDA: 21CFR Part 11). Ideally experienced in the Medical Technology Sector. A knowledge of important IT Standards & Methods (eg ISO27001 more »

support and technical direction for the generation and maintenance of the system Design Assurance Checks. Regular attendance is an essential job function. Will spend part of his/her time as a member of continuous improvement teams undertaking projects and seeking ways to improve the quality of products and … duties as assigned by supervisor. KNOWLEDGE, SKILLS, ABILITITES: Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001) Communicates well with required project contacts, seeks to communicate, and form relationships with non-required contacts. Experience with all of the … departments globally. Your Benefits Medical/Dental/Vision including a state-of-the-art wellness program and pet insurance, too! 3 weeks vacation, 11 holidays plus paid sick time Up to 8 weeks of 100% paid company parental leave 401(k) retirement savings plan providing a match of more »