Internal Operations QA Specialist

Il y a 3 jours

Eigenbrakel, Waals-Brabant, Belgique Pauwels Consulting Temps plein 55 000 € - 85 000 € Contrat

Our client, a leading biopharmaceutical organization, is seeking a professional to support their biological development activities. This role combines operational shop floor presence with administrative quality assurance tasks to ensure compliance during the manufacturing of early-stage biologics. The project requires high adaptability in a dynamic environment where priorities can change frequently.

  • Participate in daily interactions and meetings with production teams on the manufacturing floor.
  • Follow manufacturing activities and monitor batches in real time to maintain compliance.
  • Perform batch record reviews and manage deviations within the quality system.
  • Execute GMP floor checks, compliance tours, and mini-audits when required.
  • Collaborate with stakeholders to solve quality issues and manage CAPA and change control processes.
  • Handle technical documentation including SOPs, protocols, and reports.
  • You have a Bachelor or Master degree in a scientific discipline.
  • You bring 3+ years of experience in a GMP environment.
  • You possess experience with quality systems including deviations, CAPA, and change control.
  • You're autonomous, proactive, and able to manage multiple priorities in a dynamic environment.
  • You have strong teamwork and communication skills.
  • You have a basic knowledge of English.

Nice to Haves

  • Previous experience in biologics production or the pharmaceutical industry.
  • Strong knowledge of regulatory requirements.
  • Comfort with stakeholder management and interest in continuous improvement.