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We’re looking for a QA Operations Officer to strengthen our Quality Assurance team. In this role, you’ll ensure compliance, oversee batch reviews, and contribute to the safety and efficacy of our life-saving products. If you thrive in a dynamic, purpose-driven environment and are passionate about quality and improvement, this role could be your next career step.
About Us:
At Prothya Biosolutions, we are on a mission to save lives through science. By harnessing the potential of blood plasma, we produce essential medicines that treat a range of severe health conditions. Our commitment to quality and innovation fuels our success, and with 1,000 dedicated professionals across the Netherlands, Belgium, and Hungary, we’re making a difference every day.
Key Responsibilities:
- GxP Compliance: Ensure all QA activities meet Good Practice (GxP) standards.
- Batch Review & QP Release: Review product batches and prepare for Qualified Person (QP) release.
- Deviations & Complaints: Manage product deviations, incidents, and complaints with a keen eye for detail.
- CAPAs & Change Controls: Lead the oversight and closure of Corrective and Preventive Actions (CAPAs) and Change Controls.
- Process Improvement: Proactively identify and implement process improvements to enhance quality standards.
- Documentation: Review and update quality documentation to maintain compliance.
Your Profile:
- Education: HBO or Master’s degree, ideally in a life sciences or related field.
- Experience: At least 2 years in a relevant quality role, with strong knowledge of GMP—experience in aseptic production is a plus.
- Technical Skills: Familiarity with quality systems such as Trackwise, MasterControl, or SAP.
- Language Proficiency: Proficient in English (excellent written and good comprehension skills) and Dutch (good reading and comprehension skills).
- Attributes: Proactive, analytical thinker with strong communication skills.
What We Offer:
- Competitive Salary: €3,892.73 - €5,595.80, with a 16.66% flexible budget.
- Work-Life Balance: 40-hour workweek with flexible hours.
- Growth Opportunities: Join a team committed to professional development and continuous improvement.
- Accessibility: Centrally located with private parking and excellent public transport connections.
- Financial Security: Robust pension plan to support your future.
Ready to Make a Difference?
If you’re passionate about quality and eager to work on projects that save lives, we’d love to hear from you! Apply today to join Prothya Biosolutions in our mission to fight against severe diseases and contribute to life-saving solutions.
Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.