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Senior Regulatory Validation Coordinator

BASF Agricultural Solutions Belgium NV · Gent

New
CDI Onsite Senior 🇬🇧 English
GAMP 5 OECD GLP FDA 21 CFR Part 11

Job description

About the role

The Senior Regulatory Validation Coordinator will execute validation and verification activities for laboratory and computerized systems, ensuring compliance with OECD GLP requirements and supporting BASF's agricultural solutions portfolio.

Key responsibilities

  • Execute validation and verification tasks for new and existing laboratory/computerized systems according to approved strategies and OECD GLP standards.
  • Prepare and maintain lifecycle documentation, SOPs, and coordinate review and approval processes.
  • Perform impact and risk assessments, recommend controls, and manage deviation investigations, root‑cause analysis, and CAPA follow‑up.
  • Coordinate calibration activities for laboratory equipment and provide first‑line IT support for assigned systems.
  • Prepare documentation for GLP audits and regulatory inspections and drive improvement initiatives.

Required profile

  • Bachelor's or master's degree in Life Sciences, Biotechnology, Chemistry, Engineering, IT or related field.
  • Professional experience in GxP validation or regulated environment, able to coordinate validation and quality activities independently.
  • Strong organizational, planning and communication skills, fluent in English.

Required skills

  • Knowledge of GAMP 5 and OECD GLP guidelines.
  • Familiarity with FDA 21 CFR Part 11 requirements (advantage).
  • Experience with laboratory system validation, data integrity and equipment calibration.

What we offer

  • Permanent position in an international, regulated environment with structured on‑the‑job training.
  • Competitive compensation, attractive benefits and opportunities for professional development and career growth.

Questions fréquentes

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Le contrat proposé est un CDI basé à Gent.

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Published 11 uur geleden

Expires over 1 maand

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BASF Agricultural Solutions Belgium NV

Gent