Logistic Compliance Specialist
Brabant-Walloon – Contracting
Our partner is looking for a Logistic Compliance Specialist to join its team.
Your responsibilities?
- Ensure Shipping Qualification is in line with the companies sop‘s and applicable referentials & standards (i.e. GDP, USP 1079, …),
- Animate Shipping Qualification project team and ensure shipping qualification deliverables are in line with the overall project milestones,
- Document shipping qualifications and associated documentation,
- Manage associated Change Controls.
- Get shipping Operational Qualification Report approved,
- Get shipping Performance Qualification Report approved ,
- Manage the creation of new datalogger set-up and update associated documentation,
- Ensure proper handling procedure is in place at supplier level,
- Report shipping qualification achievements and planning follow-up to project Core Team.
- Manage project change control(s), including impact analysis, submission to CC board and validation, follow-up in company eQMS…
- Manage Operational Qualification study:
- Write OQ protocol, manage review workflow, integrate comments, manage approval workflow,
- Coordinate the study with the companies CLO (manage shipment requests, quotation, test execution follow-up, …),
- Write associated OQ report, manage review workflow, integrate comments, manage approval workflow,
- Write PQ protocol, manage review workflow, integrate comments, manage approval workflow,
- Coordinate PQ shipments with the supplier and internal stakeholders (including Global Logistics),
- Write associated PQ report, manage review workflow, integrate comments, manage approval workflow
- Manage datalogger set-up creation (SAP ref., Quality Agreement update, associated QA documentation update…),
- Set-up appropriate handling procedure and update relevant QA associated documentation for Global Logistics operations,
- Provide SME support and training to key stakeholders including supplier, Global Logistics Operations, Quality teams etc,
Your profile?
- Fluent in English,
- Working knowledge of GMP/GDP regulations,
- Proficient with qualification exercises,
- Understands basics of logistics operations,
- Ability to manage the “grey zone”, balance multiple priorities,
- Able to work within an international team environment and good team player.
