Monday, October 27, 2025
Rousselot Gent

Quality Assurance & Validation Specialist Biomedical

Posted: 3 days ago

Job Description

Location: Ghent, BelgiumCompany: Rousselot – global leader in gelatin and collagen production for biomedical, pharmaceutical, food, and technical industriesRousselot Biomedical is seeking a Quality Assurance & Validation Specialist to help ensure that all biomedical products are manufactured, packaged, stored, and distributed in full compliance with current Good Manufacturing Practices (cGMPs).You’ll join a collaborative team and report to the Quality and Compliance Manager Biomedical to uphold quality and drive improvements across our operations.Area of responsibility and related tasks:• Quality AssuranceDisposition of finished product batches & preparation of certificates of analysisIncoming release of materials and packaging componentsInvestigation and resolution of non-conformances, deviations, and complaintsApproval of change controls and supplier qualificationsManagement of specifications, QMS documentation and training programPerforming internal auditsSupport during customer and authority audits, including CAPA follow-upDocumentation support towards customers• ValidationDevelopment of validation masterplans, protocols (IQ/OQ/PQ) and related documentationExecution of validation tests and coordination with external partnersOversight of process validation activities and QC resultsOwnership of re-qualifications and centralized validation archiveContribution to risk assessments (FMEA)Profile2–3 years of experience in the (bio)pharmaceutical industry with working knowledge of GMP (EU & US)Skilled in root cause analysis and structured problem-solvingStrong communicator with the ability to influence and collaborate across teamsProficient in Dutch and EnglishOrganized, detail-oriented, and proactiveWe offer the opportunity and challengeImpact: Your expertise will directly shape product quality and validation, fueling innovation in life sciences.Growth in a Global Leader: Be part of an international organization recognized for its pioneering role in gelatin and collagen for biomedical applications.Learning That Lasts: Expand your skill set in GMP compliance, Quality Management Systems and validation technologies in a supportive environment.🕰️ Timing is everything. All applications will be reviewed the 9th of October the latest. Thanks for your patience—we’ll be in touch soon!

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