QP Netherlands

We are seeking an experienced Qualified Person (QP) to join our client's Amsterdam‑based Quality team.

This is a pivotal role ensuring that all sterile and plasma‑derived products meet the highest standards of EU GMP compliance and patient safety. The successful candidate will bring deep expertise in aseptic manufacturing, plasma fractionation, and biologics, and will thrive in a fast‑paced, highly regulated environment.

Key Responsibilities

• Act as EU‑licensed QP for batch certification in accordance with Directive 2001/83/EC and EU GMP
• Review and approve batch documentation, ensuring compliance with Annex 1 (sterile manufacturing) and Annex 14 (plasma products)
• Provide quality oversight for manufacturing, aseptic processing, and fill-finish operations
• Lead/support regulatory inspections (EMA, FDA, WHO) and client audits
• Collaborate cross‑functionally to resolve deviations, CAPAs, and change controls
• Review and approve validation protocols/reports for equipment, facilities, and processes
• Drive continuous improvement of quality systems and operational excellence initiatives
• Mentor QA staff in GMP compliance and sterile manufacturing best practices

Requirements

• EU‑eligible Qualified Person status under Directive 2001/83/EC
• Minimum 5-7 years' experience in GMP‑regulated biotech, plasma‑derived products, or sterile manufacturing
• Strong working knowledge of Annex 1 and Annex 14
• Proven track record in batch release, inspection readiness, and regulatory compliance
• Experience with facility/equipment qualification and validation lifecycle
• Excellent communication skills in English; Dutch or German advantageous
• Availability to work on‑site in Amsterdam and start at short notice

Why Apply

• Opportunity to work with cutting‑edge biotech and plasma‑derived therapies
• Collaborative, high‑performance culture with a focus on patient safety and innovation
• Immediate start in a role with significant impact on product quality and patient outcomes
  
  Immediate start. High-impact role. Apply now!