Qualified Person (QP)

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.

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

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
• Clear communicator
• Shows sense of urgency and sensitive for the needs of the organization
• Excellent writer
• 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.

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.