Aseptic Filling QA Engineer Flexible Hours

Prothya Biosolutions Netherlands B.V; Netherlands; Remote; EUR 47,000 - 67,000; Full time

Benefits offered by this job

8.33% end-of-year bonus

8.33% holiday allowance

30 holiday days

Personal training budget €2,100 every

Job summary

Prothya Biosolutions Netherlands B.V is seeking a Quality Engineer to support production activities, with a focus on aseptic filling, and to perform deviation investigations and impact assessments on the shop floor. You will lead deviations/OOS/OOT investigations, propose corrective actions, act as the primary contact for production quality issues, and mentor new QE as needed.

The role requires strong knowledge of cGMP and GxP, cross‑functional collaboration, and a commitment to a quality

Qualifications

• >3 years in pharmaceutical quality/production
• Experience with aseptic filling is required
• Strong understanding of cGMP and quality systems
• Proficient in root cause analysis tools (5Why, 5M, Is/Is not)
• Excellent written and verbal communication
• Proactive problem solving and teamwork

Responsibilities

• Lead deviation and OOS/OOT investigations with root cause analysis
• Propose corrective and preventive actions and assess product impact
• Be primary QE contact for production quality issues and advise immediate actions
• Mentor new Quality Engineers as needed
• Ensure GxP compliance and write SOPs and deviations
• Maintain safe, secure, and healthy work environment and cross‑department collaboration

Skills

Aseptic filling

Deviations investigation

Root cause analysis

Communication

Proactive problem solving

Teamwork

Mentoring

Tools

GxP knowledge

Job description

Prothya Biosolutions Netherlands B.V is seeking a Quality Engineer to support production activities, with a focus on aseptic filling, and to perform deviation investigations and impact assessments on the shop floor. You will lead deviations/OOS/OOT investigations, propose corrective actions, act as the primary contact for production quality issues, and mentor new QE as needed.

The role requires strong knowledge of cGMP and GxP, cross‑functional collaboration, and a commitment to a quality