logistics compliance specialist - 14324.

As a Quality Logistics Compliance Specialist, here will be your following responsibilities:

• Ensure Shipping Qualification is in line with our customer's sop‘s and applicable referentials & standards (i.e.GDP, USP 1079, ...),
• Animate Shipping Qualification project team and ensure shipping qualification deliverables are inline 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 our customer's eQMS...
• Manage Operational Qualification study:
• Write OQ protocol, manage review workflow, integrate comments, manage approval workflow,
• Coordinate the study with our customer CLO (manage shipment requests, quotation, test execution follow-up, ...),
• Write associated OQ report, manage review workflow, integrate comments, manage approval workflow,
• Manage Performance Qualification study:
• 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,

For the position of Logistics Compliance Specialist, we expect the following competencies and skills:

Education

• Master’s degree required in analytical sciences: chemistry, biochemistry, biology, supply chain

• Fluent in English, and French is a plus

• 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.