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GxP Consultant

GxP Guideline Consulting · Région flamande

New
Hybrid 🇬🇧 English
CSA CSV IT compliance Risk management SOP writing

Job description

About the role

We are looking for a GxP Consultant to join our young consulting firm within the De Cronos Group. The role combines hands‑on GxP compliance expertise with an entrepreneurial drive to help grow the company and support life‑science clients in meeting regulatory standards.

Key responsibilities

  • Contribute to company strategy, service offering and knowledge framework.
  • Support recruitment, onboarding and team structuring.
  • Build and maintain client relationships, facilitate workshops and translate regulatory requirements into practical solutions.
  • Act as a trusted advisor on validation approaches using CSA/CSV/SDLC methodologies.
  • Design and optimise Quality Management Systems, write SOPs and guide clients through complex GxP projects.
  • Assist clients in adopting novel technologies within regulated environments.

Required profile

  • Proven experience in CSA, CSV, IT compliance, risk management and QMS within life‑science organisations.
  • Background in consulting or complex stakeholder environments.
  • Entrepreneurial mindset with ownership and leadership qualities.
  • Comfortable working across projects, processes and people.

Required skills

  • CSA (Computer System Validation)
  • CSV (Computer System Validation)
  • IT compliance
  • Risk management
  • Quality Management System (QMS) design
  • Validation methodologies (CSA/CSV/SDLC)
  • SOP writing
  • Process optimisation

What we offer

  • Ownership, autonomy and impact in a growing consultancy.
  • Opportunity to evolve into a key position within the company.
  • Exposure to top‑tier life‑science environments.
  • A culture focused on quality, pragmatism and people.

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Published 1 week geleden

Expires over 1 maand

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GxP Guideline Consulting

Région flamande