Senior Quality Engineer – Lead Investigations & CAPA Excellence

Prothya Biosolutions; Amsterdam; On-site; EUR 52,000 - 75,000; Full time

Benefits offered by this job

Flexible hours

Full-time

Holiday allowance

13th month

Training budget

Travel allowance

Public transport access

Private parking

Pension plan

Job summary

Prothya Biosolutions in Amsterdam seeks a Senior Quality Engineer to lead complex investigations and drive quality enhancements within our Technical Operations. You will manage CAPAs, perform risk-based assessments, and ensure compliance with cGMP and GxP requirements.

You will mentor QE staff, collaborate across departments, and contribute to a culture of continuous improvement while supporting production continuity and patient safety.

Qualifications

• 5 years of experience in a comparable role as a technical Quality Engineer within the pharmaceutical sector.
• Deep understanding of pharmaceutical production processes, cGMP, and Quality systems.
• Technical proficiency in manufacturing processes, equipment, and products.
• Skilled in risk analysis tools, data analysis and engineering principles.
• Excellent written and verbal communication and strong leadership.
• Proactive problem-solving approach.

Responsibilities

• Lead in-depth investigations into complex deviations, ensuring cross-department collaboration to achieve right-first-time resolutions.
• Perform Process Assessments when defining CAPAs and conduct Product Impact Assessments for quality and safety implications.
• Maintain production continuity by addressing complex technical, process, and material issues.
• Conduct Gemba walks to observe and analyze processes on the shop floor.

Job description

Prothya Biosolutions in Amsterdam seeks a Senior Quality Engineer to lead complex investigations and drive quality enhancements within our Technical Operations. You will manage CAPAs, perform risk-based assessments, and ensure compliance with cGMP and GxP requirements.

You will mentor QE staff, collaborate across departments, and contribute to a culture of continuous improvement while supporting production continuity and patient safety.