Proficiency in project management tools (e.g., MS Project, JIRA, Confluence, Power BI). Desirable Qualifications: PRINCE2, PMP, or Agile certification. Familiarity with ITIL or service management principles. Life Science GxP knowledge Clarity PPM and AgilePPM (DSDM) knowledge would be a plus More ❯
Veeva Vault migration (Quality, Regulatory, Clinical, or Commercial). Hands-on knowledge of Veeva Vault Loader, APIs, or other ETL tools (e.g. Boomi, Informatica, Talend). Strong understanding of GxP, 21 CFR Part 11, Annex 11, and cloud system validation. Excellent stakeholder and vendor management skills. Confident working with complex datasets and metadata. Fluent in English; additional EU language(s More ❯
KGaA. Today, Generis serves more than 600,000 users worldwide, across use cases ranging from RIM, Regulatory/R&D and Safety use cases to Clinical, Non-clinical, Quality GxP, CMC, Pharmacovigilance, Medical Information/Medical Affairs applications and more. Our mission Our mission is to provide industry-defining implementations that are fast and intuitive to bring our customers an More ❯
regulated software testing while exploring emerging technologies in the cloud, IoT, and device space. You may also have some of the following, though they are not essential: Experience with GxP or GAMP5 frameworks Familiarity with automated testing tools or frameworks Exposure to electronic QMS systems such as Cognidox, Ketryx or others Understanding of Agile or Scrum methodologies A Word on More ❯
