Contracting – Brabant Wallon Business Analysis: conduct stakeholder interviews, process mapping, and current state assessments across CMC Dev laboratories to translate & align needs into clear requirements or user stories, and testing scripts / criteria. ELN template Design & Development: Apply established processes & style guide to design and configure ELN experiment templates, forms, calculation sheets, workflows, approval steps, audit trails, etc. ELN structured data structuration: Configure data mapping according to CMC data models ensuring data/metadata schemas are aligned to FAIR principles and scientific and industry domain standards Optimize usability and search/discovery/re-usability (naming conventions, taxonomies, tagging, template reuse, Inventory), & integration with other computerized systems Implement or coordinate & monitor development, testing, issues/defects identification, prioritization & fixes Ensure fit for purpose of Digital Operations solutions, and solution & business readiness for implementation – further support change management by monitoring the adoption and performance of newly implemented solutions Deliver process and solutions documentation, datasets and trainings Contribute to solutions lifecycle with change requests, impact assessment and continuous improvement Hands-on expertise configuring and developing within IDBS E‑WorkBook (on premise or Cloud) or similar ELN solution Hand-on experience and strong understanding of CMC Development laboratory workflows (small molecules, biologics, analytical development, sample & inventory management) Business Analysis & Product Skills with demonstrated proactiveness, curiosity, analytical and self-reliant mindset Knowledge of regulatory requirements and quality standards in the biopharmaceutical industry is a plus Excellent communication, interpersonal and facilitation skills Continuous improvement and customer-centric thinking, but balanced with an ability to challenge legacy landscape Jefferson Wells offers you a permanent cont... Legacy, Physical inventory, Prioritize Workload, Impact Assessment, Business analysis, Business, Work Streams, Dataset, Biopharmaceuticals, Data models, Development, Design, Biopharmaceuticals, Change Requests, Coordination, Practicality, Calculation, Industry Science, Operations, Full Life Cycle, CMC, Implementation, Facilitation, Design Development, Structured Data, Metadata, Business readiness, Documentation, Communication, Audit Trail, Templates, User Experience, Laboratory Work, Monitoring, Training, Cloud, Data Mapping, Taxonomy, VOS, Quality Control, ELN, Test Script, Naming Conventions, Customer Oriented, Landscaping, Testing, Style Guide, Change Management, Process Mapping, User Story Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be!
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