Open role
Qualified Person
Prothya Biosolutions Netherlands B.V.
About the role
Your job:
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
What you'll bring
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
Clear communicator
Shows sense of urgency and sensitive for the needs of the organization
Excellent writer
Fluent in English and professional level of Dutch
Ability to work on-site
What's on 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.