Senior Qualified Person - GMP & QMS Leader

Prothya Biosolutions Belgium BV; Netherlands; Remote; EUR 82,000 - 117,000; Full time

Benefits offered by this job

Flexible working hours

Salary between €7,303.56 and €10,498.,

Job summary

Prothya Biosolutions Belgium BV seeks a Qualified Person (QP) in Quality Assurance to certify finished products and ensure GMP compliance under MIA/MA terms. The role covers blood plasma release and Annex 14 responsibilities, with on-site duty and cross-functional collaboration.

Requirements include a Pharmacist or MSc in relevant fields, 5+ years in pharma, and fluent English with professional Dutch. The position offers 36–40 hours, salary and strong growth opportunities in a dynamic setting.

Qualifications

• Pharmacist or MSc in Pharmaceutical Sciences or regulatory equivalent.
• Minimum 5 years in healthcare/pharmaceutical industry.
• Solid experience as QP in biotech/pharma manufacture.
• Fluent English and professional Dutch language.

Responsibilities

• Perform EU QP certification for all products under Prothya Biosolutions B.V. responsibility.
• Ensure Quality Compliance with national and international regulations.
• Oversee QMS, including Quality Management Reviews and Product Quality Reviews.
• Maintain Manufacturing License and approve related investigations.
• Coordinate with departments to ensure proper communication to authorities.

Skills

Fluent English

Dutch proficiency

Persuasiveness

Decisiveness

Education

Pharmacist/MSc in Pharmaceutical Sciences

Job description

Prothya Biosolutions Belgium BV seeks a Qualified Person (QP) in Quality Assurance to certify finished products and ensure GMP compliance under MIA/MA terms. The role covers blood plasma release and Annex 14 responsibilities, with on-site duty and cross-functional collaboration.

Requirements include a Pharmacist or MSc in relevant fields, 5+ years in pharma, and fluent English with professional Dutch. The position offers 36–40 hours, salary and strong growth opportunities in a dynamic setting.