Global Transport Validation Expert – Lessines, Belgium – 6 Month Contract
Nicholas Howard Limited are delighted to be recruiting for a new and exciting role as a Global Transport Validation Expert.
Based in Belgium, this position is part of Global Transportation and is responsible for assuring that products are transported under proper conditions and that shipping solutions and processes are qualified in compliance with Quality and Regulatory Agencies requirements.
This position requires demonstrated skills to act as a subject matter of GDP compliance on shipping solutions and processes within transportation and distribution network, supporting multiple sites and CMO’s.
This position contributes to the improvement of baseline SC transport and distribution spend by continuously seeking opportunities to improve existing solutions, processes and performance across the logistics network.
- Perform shipping solutions and processes qualification by:
- Assessing Vendor data (OQ) for active and passive solutions used in transportation and replenishment.
- Performing shipping qualification studies (PQ) considering holistic approach on global transportation and replenishment processes (mainly for Air to Sea initiatives).
- Performing Transportation Risk Assessments following Transport Validation requirements.
- Working with multiple Sites and CMOs, SC&D QA and logistics operations to ensure that products are shipped with compliant and efficient solutions (solutions and processes).
- Monitoring end-to-end performance of shipping solutions, perform trending analysis.
- Maintain validation master plans for Shipping solutions and processes, perform change control activities and maintain database of qualified solutions.
- Lead Logistics Provider (LLP) implementation: support LLP project to ensure GDP compliance for shipping processes.
- Non-Conformance: Support evaluation and management of temperature deviations in transportation and replenishment operations.
- Develop and implement standards and SOPs for supporting the assessment, qualification, implementation, continuous improvement and lifecycle management of all distribution solutions (solutions and processes).
- Act as a subject matter of GDP compliance on shipping solutions and processes by managing through lifecycle, harmonizing and continuously improving quality and efficiency of distribution solutions.
Education & Experience:
- Experienced with multiple PM tools and processes. High level of MS office tools (Word, Powerpoint, Excel, Access, Project).
- Bachelor’s degree / Advanced degree in Engineering or at least 4yrs of related experience in Supply Chain / Validation in a GMP / GDP environment preferred.
- Fluent in both spoken and written English language.
- Hands-on experience and exposure to technologies applicable to logistic validation and thermal packaging engineering validation.
- Proven knowledge and application of cGMP requirements and demonstrated application of industry guidance / standards documents (e.g. ISTA, ASTM, ISPE, PDA, ISO, ICH, Pharmacopeias) and Regulatory CMC guidance documents applicable to the role.
To be considered for this position please apply below.