Senior Quality Engineer, Technical Operations | Impact

Prothya Biosolutions; Amsterdam; On-site; EUR 47,000 - 67,000; Full time

Benefits offered by this job

Flexible working hours

13th month

Holiday allowance

Travel allowance

Pension plan

Professional development budget

Public transport access

Parking

Job summary

Prothya Biosolutions is seeking a Quality Engineer in our Technical Operations department to support daily production activities, including deviation investigations and impact assessments on the shop floor.

You will lead root cause investigations for deviations, OOS/OOT, and contribute to continuous improvement while ensuring GxP compliance and proper documentation. A proactive, collaborative mindset is essential to drive quality across production teams.

Qualifications

• 3+ years of experience in pharmaceutical industry, preferably with sterile manufacturing.
• Deep understanding of pharmaceutical production processes, current Good Manufacturing Practices (cGMP), and Quality systems.
• Preferably skilled in root cause analysis tools (5M, 5x why, Is/Is not methodology...)
• Excellent communication skills, both written and verbal
• Proactive approach to problem-solving
• Strong team working mindset and ability to work independently

Responsibilities

• Lead the Deviations/OOS/OOT investigation with adherence to procedures and training.
• Act as QE representative during client complaints investigations and suggest improvements.
• Support/demine training for other QE team members as needed.
• Ensure a safe, collaborative work environment and cross-functional cooperation.
• Attend production meetings and monitor for potential issues to prevent deviations.
• Provide immediate actions and coordination with QA for production quality issues.
• Contribute to GxP compliance by documenting deviations and change controls.

Skills

Root cause analysis

Quality systems

Communication

Problem solving

Teamwork

Independent work

Tools

5M methods

5x why

Is/Is not methodology

Job description

Prothya Biosolutions is seeking a Quality Engineer in our Technical Operations department to support daily production activities, including deviation investigations and impact assessments on the shop floor.

You will lead root cause investigations for deviations, OOS/OOT, and contribute to continuous improvement while ensuring GxP compliance and proper documentation. A proactive, collaborative mindset is essential to drive quality across production teams.