GMP Compliance

  • Location: Wavre
  • Type: Contracting
  • Job #16464

Quality & Regulatory Compliance

Contracting – Walloon Brabant

#Quality #Regulatory #GMP #CMC #Coordination #pharma

You have experience in coordination and compliance tasks? You speak fluently English? You are stress resistant? Keep reading your future job description.

Our partner is looking for a Quality & Regulatory Compliance to join its team. This international company is well-known for its pharmaceuticals.

What are your responsibilities?

  • Deliver the global documentation updates linked to the site conformance and regulatory compliance processes in compliance with quality requirements.
  • Act as QA partner for change control boards
  • Lead the governance and ensure alignment across the different sites
  • Participate as partner for Global Supply Chain change control boards
  • Deliver and implement initiatives and improvement programs management
  • Ensure the continued compliance in collaboration with local Site Conformance network and technical regulatory department across the whole organization
  • Ensure close collaboration with regulatory affairs teams
  • Provide quality oversight to the CMC regulatory processes
  • Participate as QA partner to RA initiatives:  improve the end-to-end CMC process
  • Ensure QA oversight for regulatory compliance change controls
  • Driving site conformance network meetings and workshops
  • Lead project-related discussions
  • Provide in-depth strategic, scientific and RA input for technical/CMC and procedural aspects
  • Provide support via critical review of the technical and procedural section of regulatory documents and templates
  • Escalate risks and issues and communication of the status of the projects

Who are you?

You hold a bachelor or master degree or equivalent experience and you have experience in coordination and compliance tasks. You speak English and French. You are a problem solver, structured, detail minded and well organized.

What can you expect?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.

You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Béatrice Stroobants: [email protected]

 

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