Brabant-Walloon - Contracting 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, 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... Logistics, Coordination, GMP, Documentation, Shipment, Impact analysis, SME, Shipping, Validation, Change Control, Management, SAP, Quality assurance, Projects, OQ, PQ, Regulation, Test Execution, Training, Planning, Quotation Originele vacature is te vinden op StepStone.be – Maak nu een Jobagent aan op StepStone en vind je droombaan! https://bit.ly/2jPYsZC Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be!
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