Our client, a global bio/pharmaceutical leader, is seeking an experienced Global Transport Validation Expert to join their team in Dublin City Centre.
This position is responsible for assuring that products are transported under proper conditions and that shipping solutions and processes are qualified in compliance with Company Quality and Regulatory Agencies requirements.
Duties and responsibilities of the Global Transport Validation Expert include:
- 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.
- Act as a subject matter of GDP compliance on shipping solutions and processes.
You will have skills and experience in the following:
- Bachelor's Degree / Advanced Degree in engineering / science or similar
- 2+ years relevant experience in the pharma industry
- Complete, in-depth understanding of all aspects of the pharmaceutical business, Cold Chain Logistics Transportation and Packaging, Good Distribution Practices
- Validation process experience
- Hands-on experience and exposure to technologies applicable to logistic validation and thermal packaging engineering validation
- Project management experience (multiple PM tools and processes)
To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.