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Qualification & Validation Responsible

EPM Scientific · Ixelles

Senior 🇬🇧 English
Metrology and calibration management GMP compliance

Job description

About the role

We are looking for an experienced Qualification, Validation & Metrology Manager to support GMP‑regulated pharmaceutical manufacturing operations in Brussels. The successful candidate will lead qualification and validation activities, oversee metrology programmes, and ensure compliance with regulatory and quality requirements across equipment, facilities, utilities, processes, and systems.

Key responsibilities

  • Coordinate and execute qualification activities for equipment, utilities, facilities, and computerized systems (IQ/OQ/PQ).
  • Support process, packaging, and cleaning validation activities.
  • Oversee calibration and metrology programmes to ensure GMP compliance.
  • Manage deviations, CAPAs, change controls, and risk assessments related to validation.
  • Prepare, review, and approve qualification and validation documentation.
  • Support internal audits, client audits, and regulatory inspections.
  • Collaborate with Quality, Engineering, Manufacturing, and external vendors to deliver compliant validation projects.

Required profile

  • Significant experience in a GMP pharmaceutical manufacturing environment.
  • Hands‑on experience in qualification and validation activities (IQ/OQ/PQ).
  • Demonstrated experience in metrology and calibration management.
  • Strong knowledge of GMP, ICH guidelines, pharmaceutical quality systems, and risk management principles.
  • Experience managing deviations, CAPAs, and change controls.
  • Excellent communication skills, attention to detail, and ability to work independently.
  • Operational level of English.

Required skills

  • IQ/OQ/PQ qualification
  • Metrology and calibration management
  • GMP compliance
  • ICH guideline implementation

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Published 3 months ago

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EPM Scientific

Ixelles