Compliance Engineer – Engineering

Il y a 4 heures

Geel, Flanders, Belgique Pauwels Consulting Temps plein

Our client is seeking a Compliance Engineer to serve as the primary point of contact for quality and compliance matters within their technical operations. This role bridges the gap between engineering, maintenance, and qualification by ensuring all processes align with rigorous quality standards.

Responsibilities

  • Manage and follow up on actions within the departmental Quality Management System (QMS).
  • Coordinate root cause investigations for deviations involving technical systems and maintenance processes.
  • Develop and oversee change controls in collaboration with production, engineering, and quality stakeholders.
  • Support the creation of CAPA plans and manage the periodic review of departmental documentation.
  • Provide technical and compliance-related guidance to the engineering and maintenance teams.

Requirements

  • You have 5+ years of relevant experience in a compliance-oriented role within the pharmaceutical industry.
  • You bring a solid background in qualification and a strong technical affinity.
  • You possess thorough knowledge of industry regulations, including Eudralex, Annex 1, ICH, and ISPE guidelines.
  • You're a proactive, solution-oriented professional with a pragmatic and decisive approach to technical challenges.
  • You have excellent communication skills and the ability to work independently in a multidisciplinary environment.
  • You are fluent in English.

Nice to Haves

  • Experience working with Veeva or similar Quality Management Systems.