Digital Specialist – Analytical Development

Il y a 5 heures

belgium belgium MSI Pharma Temps plein
pbDigitalSpecialist–AnalyticalDevelopment /b bLocation: /b Brainel'Alleud, Belgium bEngagement Status: /b Freelance position until end of December 2026 (strong potential extension) h3Overview /h3 pWe are supporting a large pharmaceutical organisation who are looking for a Digital Specialist–Analytical Development to support a major digital transformation within an Analytical Development Sciences environment, part of CMC. This role sits at the intersection of analytical laboratories, digital solutions, and regulatory compliance, supporting analytical method development and stability activities from early clinical phases through life‑cycle management. The environments span both GSP and GMP. The position is embedded in large‑scaled digital transformation program driven by FDA digital submission requirements, with a strong focus on structured, traceable, and regulatory‑ready analytical data. /p h3Key Responsibilities /h3 ul liAct as a bridge between analytical development scientists, quality, IT, and digital teams /li liAnalyze existing laboratory processes and data flows /li liPerform end‑to‑end process and data mapping /li liTranslate scientific and business processes into structured data requirements /li liChallenge IT and digital solutions from a business and user perspective /li liEnsure compliance by design (GxP, ALCOA+) /li liSupport deployment of digital tools and assist end‑users /li liFacilitate discussions between stakeholders and drive pragmatic, aligned solutions /li /ul h3Requirements /h3 ul li3–8 years of professional experience /li liProven experience in data mapping, data flow design, business analysis, or data analysis /liliStrong understanding of GxP environments and ALCOA+ principles /li liExperience working at the interface between business and IT /li liFluent in English (mandatory) /li /ul h3Hard Skills /h3 ul liTranslating laboratory workflows into structured digital and data requirements /li liProcess mapping and data flow design /li liRegulatory and compliance‑driven digital solutions /li liExperience with regulated environments (GxP) /li liNice to have: /li liCMC, Analytical Development, or QC laboratory exposure /li liELN (e.g. IDBS), LIMS (e.g. LabWare), PowerBI /li liData governance or data engineering concepts /li liExperience in digital transformation programs /li /ul h3Soft Skills /h3 ul liStrong stakeholder management and communication skills /li liBusiness‑oriented mindset with the ability to challenge constructively /li liAbility to structure complex discussions and align diverse stakeholders /li liPragmatic, solution‑driven approach /li liComfortable working in cross‑functional, international environments /li /ul /p