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Qualified Person (QP) – Hybrid

QbD Group · Région flamande

Hybrid 🇬🇧 English
Batch certification GMP compliance Quality risk assessment Change control

Job description

About the role

QbD Group is seeking a certified Qualified Person (QP) to join its hybrid team and support pharmaceutical and biotech clients across Europe. You will apply your GMP expertise to ensure product quality, patient safety, and regulatory compliance.

Key responsibilities

  • Perform batch certification and support batch release activities.
  • Provide GMP oversight and ensure compliance with EU GMP requirements.
  • Review and approve deviations, CAPAs, change controls, and quality risk assessments.
  • Support manufacturing operations, including sterile and aseptic environments.
  • Prepare for and support audits, inspections, and interactions with health authorities.
  • Act as a trusted quality partner for Production, QC, QA, Engineering, and Regulatory Affairs.
  • Drive continuous improvement initiatives within quality systems.

Required profile

  • Master's degree in Pharmaceutical Sciences (Industrial Pharmacist) or a related scientific discipline.
  • Certified Qualified Person (QP) according to EU regulations.
  • Proven experience in GMP‑regulated pharmaceutical environments.
  • Hands‑on experience with batch certification and release.
  • Strong knowledge of EU GMP requirements and pharmaceutical quality systems.
  • Experience with deviations, CAPAs, change controls, audits and regulatory inspections.
  • Fluent in Dutch and English.

Required skills

  • Batch certification
  • GMP compliance
  • EU GMP regulations
  • Quality risk assessment
  • Deviation management
  • CAPA management
  • Change control
  • Audit preparation
  • Sterile manufacturing knowledge

What we offer

  • Access to a strong network of experts and continuous knowledge sharing.
  • Variety of consultancy projects combined with the stability of a single employer.
  • Opportunities for professional growth in a fast‑growing international team.

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Published 2 maanden geleden

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QbD Group

Région flamande