Junior Sterilisation Validation Analyst

Il y a 2 jours

PuursSintAmands, Antwerpen, Belgique Pauwels Consulting Temps plein 42 000 € - 62 000 € Contrat

Our client, a prominent pharmaceutical organization, is seeking a professional to join their validation team. The role focuses on drafting protocols and defining sterilization approaches for various equipment projects in compliance with strict quality standards.

  • Draft test protocols and reports for sterilization validation in accordance with cGMP and regulatory standards.
  • Plan and monitor the practical implementation of validation tests for revalidations and requalifications.
  • Investigate deviations or non-compliant results to identify root causes and suggest improvements.
  • Maintain and update necessary GMP documentation throughout the project lifecycle.
  • Coordinate activities within the team and communicate progress and deadlines to project stakeholders.
  • Support the transfer of projects to routine programs through team training and development.
  • Participate in site audits and contribute to continuous improvement initiatives for process optimization.
  • Bachelor or Master in Industrial, Civil, or Bio-engineering, Industrial Pharmacy, or equivalent experience.
  • You have 1+ years of experience in similar projects within a GMP environment.
  • You possess proficiency in standard PC software applications and have a keen interest in measurement technology.
  • You bring strong organizational skills and the capacity to work in an accurate and creative manner.
  • You are fluent in Dutch and English with strong technical writing skills.

Nice to Haves

  • Prior experience specifically within sterilization validation.
  • Willingness to work in a shift system.