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NL Compliance Officer (Trade & Healthcare GDP)

Expeditors · Rozenburg

New
Mid 🇬🇧 English
GDP CAPA Change control

Job description

About the role

Expeditors is looking for a Dutch-speaking Compliance Officer in Rozenburg, working a combined role split between Trade Compliance (3 days) and Healthcare Compliance (2 days). The position supports the Trade Compliance team and acts as backup for the Branch DCM, while also serving as Deputy Responsible Person for healthcare, supporting the NL RP/DP (Healthcare Manager).

Key responsibilities

  • Ensure district-level compliance with company policies and trade laws and regulations.
  • Maintain full RP/DP qualification and license registration, and support GDP compliance in AMS and WDA license requirements.
  • Support the DCM in building a compliance culture, run regular audits on trade compliance topics and help implement preventive controls and corrective actions.
  • Handle quality risk management, CAPA, change control and performance indicator reviews for healthcare GDP.
  • Support training programmes, keep personnel trained in trade compliance and GDP, and monitor training records.
  • Maintain GDP standards for own and contracted storage premises, including temperature mapping, equipment calibration and validation, and accurate record keeping.
  • Assist operations with screenings, file audits and monthly branch assessments, report anomalies and support due diligence checks.
  • Support recalls, complaints, returns and suspected falsified medicines, and cooperate with marketing authorization holders and national competent authorities.
  • Audit GDP-approved service providers and ensure self-inspections follow a prearranged programme.
  • Apply cold chain, ambient and hazardous transport requirements and ensure transport equipment is qualified.
  • Act as Designated Person for Active Substances under Directive 2011/62/EU, remaining contactable when the RP/DP is absent.

Required profile

  • Prior relevant knowledge and experience in compliance and the distribution of medical products.
  • Knowledge of local Dutch regulations on wholesale distribution of medicinal products.
  • Knowledge of the European Pharmaceutical Directive on wholesale distribution.
  • Good Distribution Practice (GDP) licence.
  • Diligent approach to duties, with full compliance with procedures and regulations.

Questions fréquentes

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Source : ats:smartrecruiters

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Published 11 uur geleden

Expires over 1 maand

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Expeditors

Rozenburg