Tipo di lavoro: Contract

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Contenuto del lavoro

Logistics Compliance Specialist

Location:Initially hybrid with 2 days in Braine, Belgium.

Contract: A full-time role until 30/11/2025 with possibility of extension

Company:A Global Biopharmaceutical Company

Role Overview:

This role focuses on qualification activities for a key project supporting the development of a critical product. The project is essential for business growth and continuity, ensuring the qualification of a third supplier in China for a critical raw material. This involves qualifying a shipping system required to transport the product under strict compliance standards.

Given the complexity of transport processes—including cold chain requirements—this project demands a rigorous qualification approach.

Key Responsibilities:

  • Equipment Qualification: Assess critical processes and establish qualification protocols for transport systems, such as dry ice shipments.
  • Protocol and Testing Management: Develop and execute qualification protocols, conduct performance analysis, and prepare detailed reports.
  • Logistics Oversight: Ensure controlled temperature transportation by coordinating transport procedures and managing equipment such as Data Loggers.
  • Project Management: Plan, execute, and monitor qualification phases, ensuring strict adherence to deadlines and quality standards.
  • Documentation Management: Draft and maintain key documents, including SOPs, qualification reports, and performance assessments.

Required Skills & Experience:

  • Minimum 4 years of experience in the pharmaceutical industry, with expertise in equipment and process qualification—preferably related to temperature-sensitive transport systems like dry ice.
  • Languages: Professional proficiency in both written and spoken English and French. Strong communication skills are required for coordination with teams in China and Switzerland.
  • Logistics Knowledge: Experience in logistics (transport flows, supplier qualification) is beneficial, though the primary focus remains on process and equipment qualification.
  • Validation Expertise: Experience in process validation and risk management within a highly regulated framework (cGMP).
  • Autonomy: Ability to work independently while receiving necessary support.

Additional Preferred Skills:

  • QMS Knowledge: Familiarity with pharmaceutical quality management systems (e.g., Veeva, Volt).
  • Flexibility: Adaptability to various tasks, including logistics flow management and transport process analysis.
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Scadenza: 06-01-2026

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