Qualified Person (QP)

Prothya Biosolutions; Amsterdam; On-site; EUR 73,000 - 105,000; Full time

Benefits offered by this job

Holiday allowance 8.33%

13th month salary

36/40 hours with flexible hours

Travel expense contribution

Public transport access and parking

Pension plan Zorg & Welzijn

Professional growth budget €2,100/3y

Dynamic, safe, growth-focused work env

Job summary

Prothya Biosolutions in Amsterdam seeks a Qualified Person (QP) / Responsible Person (RP) to certify finished products and ensure GMP compliance for all batches. You will release plasma and intermediates per Annex 14 and oversee QP responsibilities across contract partners.

The role requires 5+ years in pharma, English fluency and Dutch conversational ability, with on-site work. Employment is 36 or 40 hours with flexible hours, and a strong focus on growth and regulatory excellence.

Qualifications

• Pharmacist/ MSc in Pharmaceutical Sciences or related field recognized by Regulatory Authority to permit QP status.
• Minimum 5 years in healthcare/pharma industry (Production, QC labs).
• Experience as a QP in biotech/pharma manufacturing.
• Fluent in English; conversational Dutch.

Responsibilities

• Perform EU QP certification for all products under Prothya Biosolutions B.V. responsibility including contract partner products.
• Ensure Quality Compliance with National and International Regulations and internal regulations.
• Oversight of QMS including Quality Management Reviews, Quality Agreements, Product Quality Reviews.
• Maintenance of the Manufacturing License.
• Approve Product Quality Complaints related investigations.
• Cooperate with departments to ensure communications to Authorities are appropriate, coordinated and approved.

Skills

Persuasiveness

Decisiveness

English fluency

Dutch conversational

On-site work ability

Education

Pharmacist/MSc in Pharmaceutical Sciences or related field

Job description

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)
• 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 conversational level of Dutch
• Ability to work on-site

Our offer:

• Employment for 36h or 40h with flexible working hours in consultation.
• Salary between € € 6.573,20 and € 9.448,98 euro 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.