Qualified Person (QP)
€6,573 - €9,448 per month
Key Skills
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. 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.
Core Responsibilities
Certify finished medicinal product batches and release blood plasma and intermediates in accordance with GMP, applicable authorizations, and regulatory requirements. Oversee quality management reviews and agreements, maintain the manufacturing license, approve complaint investigations, and coordinate appropriate communications with authorities.
Requirements
Requires a relevant pharmacy or scientific degree recognized for Qualified Person status under Article 49 of Directive 2001/83/EC, at least five years of healthcare or pharmaceutical industry experience, and experience as a QP in biotech or pharmaceutical manufacturing. Candidates should be persuasive, decisive, clear communicators and strong writers, fluent in English with conversational Dutch, and able to work on-site.
Benefits
- Flexible Working Hours
- Holiday Allowance
- 13th Month Payment
- 30 Holiday Days
- Personal Training Budget
- Travel Expense Contribution
- Public Transport Accessibility
- Private Parking
- Pension Plan
- Professional Growth Opportunities
About Prothya Biosolutions
Industry: Pharmaceutical Manufacturing
Company size: 1,001-5,000 employees
Prothya Biosolutions was formed in 2021, when Plasma Industries Belgium (PIBe), with roots in the Belgian Red Cross, integrated with Sanquin Plasma Products (SPP), a former subsidiary of the Sanquin Blood Supply Foundation (Stichting Sanquin Bloedvoorziening). Prothya Biosolutions offers over 60 years of experience in the collection of blood plasma and production of plasma-derived medicinal products, and a long legacy of collaboration, innovation, and delivery of science-based solutions. Thanks to our diverse background, we recognize the unique value of plasma-derived medicinal products for people and society, and reflect this in our ongoing transformation into a results-driven and global organization. Stable plasma derivatives such as clotting factors, immunoglobulins and albumin solutions are produced with the fractions isolated by Plasma Industries. At Prothya, we believe the best medicines are already in your body. The human plasma proteome holds the promise of a revolution in disease diagnosis and therapeutic treatment. We will continue to play a leading role in discovering how the abundance and structure of proteins can change the way we treat human diseases. Prothya Biosolutions processes around 3 million liters of plasma each year for several international partners. This change in focus entailed a change in corporate culture. Prothya has a clear vision we call DRIVE, embodying the core values on which our organization is founded. Do you want to play an active role in improving the health of millions of patients? Would you like to be our partner or future colleague at the forefront of new developments in the Protein Therapy Development, Processing and Manufacturing? Then you are welcome at Prothya Biosolutions!