Quality Engineer
I am currently seeking a passionate Quality Engineer to join my leading Biopharmaceutical client Leiden. As an Quality Engineer, you'll play a pivotal role in ensuring the highest standards of quality in our biopharmaceutical products, ultimately contributing to improved patient care worldwide.
RESPONSIBILITIES
- Lead and oversee medium and high-impact quality investigations, including root cause analysis and corrective action and preventive action (CAPA) management.
- Assume the role of change control (CC) lead for operations, guiding change control processes from initiation to successful completion.
- Provide support for process enhancements resulting from updates to materials, equipment, facility, and biotherapeutic products, including the introduction of new products.
- Collaborate closely with stakeholders to drive quality improvement initiatives within the Operations Biotherapeutics division.
- Serve as a Subject Matter Expert on deviations and change controls during inspections and audits.
- Ensure meticulous documentation and precise completion of quality records to maintain compliance.
- Monitor the progress of quality investigation and change control processes, tracking key performance indicators (KPIs).
- Spearhead process excellence initiatives to continuously enhance both work processes and personal skills.
PROFILE
- Bachelor's or master’s degree in biotechnology, biochemistry, biomedicine, process technology, or equivalent field.
- Strong analytical capabilities, with the ability to address complex issues effectively.
- Adaptability to manage shifting priorities and evolving tasks.
- Innovative mindset, consistently seeking to improve work processes and the work environment.
- Prior experience in change control or quality investigations.
- Familiarity with Trackwise QEM system.
- Excellent English communication skills, both written and verbal (required)
- Proficiency in Dutch (required)
INTERESTED?
If you are interested in the above description, please apply with your CV today. Interview and offer can happen over the coming 2 weeks. For more information, please contact Merel van Os on +31 (0)20 20 44 502 or by e-mail at m.vanos@panda-int.com