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At Prothya Biosolutions, maintaining the highest standards in distribution is at the core of our mission. We’re seeking a diligent Responsible Person (RP) / Designated Person (DP) to ensure that our distribution practices align with the EU Good Distribution Practice (GDP) guidelines.
Location: The Netherlands
Department: Medical Affairs
Reports to: Chief Medical Officer
Your role at a glance:
As the RP/DP, you’ll be responsible for maintaining our distribution license and overseeing our Quality Management System (QMS) for GDP compliance. You’ll take the lead in managing recalls, addressing product quality complaints, and ensuring the safety and compliance of distributed medicinal products and active substances.
Key responsibilities include:
- Maintaining the Distribution License in line with EU GDP guidelines.
- Managing and maintaining a compliant QMS for GDP.
- Leading inspections and follow-up communication with regulatory authorities.
- Overseeing self-inspections and ensuring corrective actions are implemented.
- Handling recalls and investigations into product quality complaints.
- Ensuring approved suppliers and subcontractors meet GDP requirements.
What we offer:
- A competitive salary in the range of €120K – €150K per year, based on experience.
- A collaborative and innovative working environment.
- Opportunities for growth and development within a key role in the organization.
- Involvement in critical distribution processes, ensuring compliance and quality from day one.
- Comprehensive benefits package, including health insurance and pension contributions.
What we are looking for:
- A Pharmacist or MSc in a relevant scientific discipline (Pharmaceutical Sciences, Medicine, Biochemistry, or similar).
- At least 3 years' experience in the healthcare or pharmaceutical industry, ideally with prior experience as an RP.
- A strong decision-maker who communicates effectively and prioritizes the needs of the organization.
About Prothya Biosolutions:
Prothya Biosolutions is a global leader in plasma-derived medicines, born from the merger of Plasma Industries Belgium and Sanquin Plasma Products in 2021. With over six decades of experience, we produce life-saving treatments for immunology and critical care, while partnering with others to further our expertise. Our mission is “Creating Value, Sustaining Life”, and we take pride in going the extra mile to improve the health of patients worldwide.
If you're passionate about ensuring safe and compliant distribution processes, we’d love to hear from you!
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.