Qualified Person

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 makes life-saving plasma medicines and is proud of it! Every day, Prothya colleagues are delighted to go the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a dynamic, growing company with an interesting history? Then the position of Qualified Person (QP) at our Quality Assurance department might be something for you! As our Qualified Person (QP)/ Responsible Person (RP) you are certifying the finished product and are responsible for ensuring that each finished medicinal product batch has been manufactured in accordance with GMP, the terms of the MIA (Manufacturing and Import Authorization), and the MA (Marketing Authorizations). Also included is the responsibility of the release of blood plasma and all further intermediates according to Annex 14.

• Perform EU QP certification for all products under Prothya Biosolutions B.V. responsibility including products of contract partners
• Ensure Quality Compliance with all National and International Regulations and internal company regulations
• Oversight of QMS (Quality Management Reviews), which includes Quality Management Reviews, Quality Agreements, Product Quality Reviews
• Maintenance of the Manufacturing License
• Approve Product Quality Complaints related investigations
• Cooperate with all necessary departments to ensure that communication to the Authorities is appropriate, coordinated and approved

Your profile:

• Pharmacist/ MSc in Pharmaceutical Sciences or one of the following scientific disciplines: Biopharmaceutical Sciences, Medicine, (Bio-)Chemistry or Biotechnology or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
• A minimum of 5 years of experience in the healthcare/pharmaceutical industry (Production, QC-labs)
• Solid experience as a QP in the biotech or pharmaceutical manufacturing industry
• Persuasiveness and decisiveness
• Shows sense of urgency and sensitive for the needs of the organization
• Fluent in English and professionallevel of Dutch
• Ability to work on-site

Our offer:

• Employment for 36h or 40h with flexible working hours in consultation.
• Salary between € 7.303,56 and € 10.498,87euro gross per month based on full-time employment.
• 8.33% holiday allowance and a 13th month payment.
• 30 holiday days (based on fte).
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.