Quality Assurance & Validation Specialist Biomedical

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!