We are 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 English Organized, 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.