Sr Engineer QA Cleaning Validation

Il y a 6 jours

Geel, Antwerpen, Belgique Pauwels Consulting Temps plein 90 000 € - 120 000 € Contrat

Our client, a leading pharmaceutical organization, is seeking a senior expert to support their production and supply chain facility. This role focuses on providing quality oversight and acting as a subject matter expert for cleaning validation activities to ensure regulatory compliance and reliable supply.

Responsibilities

  • Assure that all cleaning validation related regulatory and procedural requirements are fulfilled.
  • Provide strategic input to the compliance improvement plan for cleaning validation.
  • Maintain quality oversight on cleaning validation actions within systemic compliance programs.
  • Review and approve validation documents such as SOPs, risk analyses, validation protocols, and trend reports.
  • Collaborate with MSAT and operations teams to introduce new cleaning validation concepts and methodologies.
  • Provide guidance on cGMP aspects for new projects and participate in multi-functional teams to achieve departmental objectives.

Requirements

  • You have a Master's degree in a scientific field or equivalent experience.
  • You bring 8+ years of experience in the pharmaceutical or chemical industry.
  • You possess expert knowledge of cleaning validation compliance including EU cGMP, ICH Q7, and 21 CFR Parts 211.
  • You have experience with quality risk management approaches such as ICH Q9.
  • You're an analytical thinker with a strong quality attitude and the ability to make risk-based decisions.
  • You are fluent in English and Dutch.

Nice to Haves

  • Experience with the introduction of new cleaning validation concepts and methodologies.