Logistics Specialist (Shipping Qualification)

工作内容

Logistics Specialist (Shipping Qualification)

Location:Hybrid with 2 days in Braine, Belgium and 3 days from home

Contract: A full-time role until February 2026

Company:A Global Biopharmaceutical Company

Role Overview: This role involves supporting products during launch phases and throughout their lifecycle. As products evolve, new shipping routes, destinations, and regulatory requirements must be considered.

A strong focus on quality is essential, as the team undergoes both internal and external GDP audits. Additionally, new documentation requirements will require the candidate to conduct quality management reviews.

Team Information

The team consists of 10 members, including both internal and external staff.

Typical Responsibilities

• Participate in regular project meetings with global teams, ensuring shipping requirements align with project objectives.
• Prepare for inspections and audits (internal/external), ensuring compliance with GDP regulations and maintaining inspection readiness.
• Engage in regular meetings with the Quality team to provide updates and align priorities.
• Act as a subject matter expert (SME) for documenting shipping qualification protocols and reports, focusing on thermal and mechanical aspects of packaging systems used in logistics.
• Provide SME support and training to key stakeholders, including market teams, CMOs, and Quality teams.
• Ensure proactive risk management by conducting comprehensive risk assessments for critical areas and ensuring response plans are implemented.
• Lead initiatives to reduce costs and CO₂ emissions in shipping systems while implementing new solutions aligned with business needs.
• Maintain audit readiness for GDP inspections (MHRA, FDA, ANVISA, and other country-specific authorities) and both internal and external audits (customers, corporate). Act as SME during these inspections.
• Drive and coordinate product shipping risk analysis and transport condition assessments for each product.
• Oversee shipping qualification for passive and active shipping systems, particularly for new product launches, packaging updates (primary, secondary, tertiary), and new product flows.
• Update and maintain standard operating procedures in collaboration with local stakeholders.
• Define data flows in systems to ensure alignment with business rules.
• Support key processes such as process validation, computer systems validation, equipment qualification, staff training, and cultural awareness, ensuring proper documentation in procedures and instructions as needed.

Experience & Requirements

• Minimum of 5 years of relevant experience in supply chain.
• Pharmaceutical industry experience is required.
• Strong understanding of both quality assurance and supply chain operations, including knowledge of GMP/GDP regulations.
• Experience implementing procedural control frameworks.
• Familiarity with audit and inspection processes.
• Solid grasp of supply chain fundamentals, from demand planning to patient distribution, including tools, terminology, and techniques.
• Strong team player with the ability to integrate seamlessly into an existing team.

Languages

• Fluency in English is required; French is a plus.