Quality Engineer

A global leader in innovative medicines and biological therapies, focused on research, analytical development, and GMP manufacturing. The site supports products from early development to commercialization through strong cross‑functional collaboration and high‑quality scientific execution.

In this role, you are responsible for supporting and leading quality assurance activities within the GET‑PEx organization. You ensure that processes meet customer, regulatory, and industry standards while driving continuous improvement. As a key quality expert, you lead investigations, support audits, strengthen documentation practices, and help build a strong quality culture across the department.

• Collaborate with Operations, QC, and QA to identify, analyze, and resolve quality issues.
• Lead NC/CAPA investigations, including risk assessments, root cause analysis, and implementation of corrective and preventive actions.
• Maintain and update the GMP training curriculum and support training compliance.
• Coordinate support for internal and external audits/inspections.
• Prepare and track weekly and monthly quality metrics, addressing any issues found.
• Manage departmental records and documentation, including archiving and ensuring data integrity.
• Share quality insights to reduce recurring issues and support continuous improvement.
• Work independently, meeting deadlines and ensuring compliance with company policies.

• Minimum 4 years of experience in the (bio)pharmaceutical industry or a relevant academic background.
• At least 2 years of experience supporting quality functions, including NC/CAPA management, GMP training, and document/record management.
• Strong proficiency in English communication, with the ability to engage effectively with stakeholders at the management level.
• Demonstrated experience using risk assessment and root cause analysis tools such as FMEA, HACCP, 5‑Whys, Ishikawa, and Kepner‑Tregoe.
• Solid proficiency in MS Office, Tableau, and electronic document management systems (eDMS).

If you're interested, please click the button below to submit your application.