Location: Ghent, Belgium
Company: Rousselot – global leader in gelatin and collagen production for biomedical, pharmaceutical, food, and technical industries
Rousselot 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 Assurance
* Disposition of finished product batches & preparation of certificates of analysis
* Incoming release of materials and packaging components
* Investigation and resolution of non-conformances, deviations, and complaints
* Approval of change controls and supplier qualifications
* Management of specifications, QMS documentation and training program
* Performing internal audits
* Support during customer and authority audits, including CAPA follow-up
* Documentation support towards customers
• Validation
* Development of validation masterplans, protocols (IQ/OQ/PQ) and related documentation
* Execution of validation tests and coordination with external partners
* Oversight of process validation activities and QC results
* Ownership of re-qualifications and centralized validation archive
* Contribution to risk assessments (FMEA)
Profile
* 2–3 years of experience in the (bio)pharmaceutical industry with working knowledge of GMP (EU & US)
* Skilled in root cause analysis and structured problem-solving
* Strong communicator with the ability to influence and collaborate across teams
* Proficient in Dutch and EnglishOrganized, detail-oriented, and proactive
We offer the opportunity and challenge
* Impact: 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!