NL Compliance Officer
Core
Ensure district-level compliance with trade laws and healthcare regulations (GDP) for medicinal product distribution, acting as backup for the Branch DCM and Deputy Responsible Person.
Role type
Senior Compliance Officer (Trade & Healthcare)
Builds
Compliance frameworks, audit reports, and quality management systems for wholesale distribution of medicinal products.
Domain
Healthcare / Pharmaceutical Distribution / Regulatory Compliance
Deliverable
client delivery | dashboards & analysis
Required skills
Trade compliance, Good Distribution Practice (GDP), Quality risk management, CAPA implementation, Change control, Regulatory reporting, Recall management, Cold chain logistics, Active Substance Registration (ASR), Audit execution, Procedure validation
Preferred skills
Knowledge of European Pharmaceutical Directives, Experience with falsified medicines detection, Stakeholder management with national competent authorities
Technologies
Computerized systems for record keeping and validation
Responsibilities
Perform regular audits on trade compliance topics and healthcare GDP deviations; Support the DCM in creating a tone of compliance and implementing preventive controls; Maintain full RP/DP qualification and license registration; Coordinate and perform recall operations for medicinal products; Ensure appropriate standards of GDP are maintained for premises and equipment; Support training programs for personnel in Trade Compliance and GDP; Apply appropriate transport requirements for cold chain and hazardous products; Manage Active Pharmaceutical Ingredients (API) & Active Substance Registration (ASR) as Designated Person.
Seniority
Senior, hands-on IC
