Quality Specialist Operations

Il y a 3 jours

PuursSintAmands, Antwerpen, Belgique Pauwels Consulting Temps plein 52 000 € - 78 000 € Contrat

Our client, a prominent pharmaceutical organization, is seeking a Quality Specialist Operations to focus on quality oversight and project support. The role involves managing operational quality tasks and ensuring compliance within a strictly regulated production environment.

  • Investigate and document quality assurance deviations and elastin issues to management in a timely manner.
  • Coordinate cross‑functional investigations for complex root causes involving manufacturing, packaging, and laboratory operations.
  • Perform root cause analyses and evaluate CAPA plans to verify effectiveness and prevent recurrence.
  • Report significant quality issues to regulatory agencies in accordance with applicable legislation and standards.
  • Participate in daily operations review meetings and multi-disciplinary process teams to ensure quality objectives.
  • Conduct trending analyses and define necessary actions based on reports to optimize performance.
  • Support continuous improvement initiatives to enhance departmental processes and key performance indicators.
  • You bring 3+ years of experience in QA within a GMP environment.
  • You have expertise in deviation management, root cause analysis, and CAPA.
  • You possess experience providing quality oversight for manufacturing, packaging, or laboratory operations.
  • You are proactive and solution‑oriented.

Nice to Haves

  • Experience with regulatory reporting for international markets.
  • Knowledge of continuous improvement methodologies.