Description
Description:
The purpose of this Global role is to:
- Act as expert for establishing Global shipping qualification and Distribution systems and solutions for Global products (API, DS, DP and FG).
- Act as expert in the Standard Practice for Performance Testing of Shipping Containers and Systems (ASTM) and simulation testing for temperature-controlled transport packaging (ISTA guidelines and procedures).
- Act as expert in Pharma requirements for temperature-controlled trailers and risk management in temperature-controlled road transportation.
- Act as the coordinator with passive and active systems suppliers and the external certified laboratory used for testing.
- Provide SME support and training to key stakeholders including markets, CMO's, Quality teams etc.
- Establish, define and maintain shipping qualification and shipping risk analysis processes that meet current standards and guidances (Good Distribution practice, Good documentation practice, ISPE cold chain management, process qualification standard and guidance, régulatory requirement)
- Set up and maintain standard templates of shipping qualification test protocols and test reports (URS, OQ, PQ) in accordance with the relevant regulations (European guidelines, PDA technical reports, USP, WHO, IATA)
- Develop and implement pharma requirements for temperature-controlled trailers and risk management in temperature-controlled road transportation.
- Risk management and risk assessment according to ICH Q 9 for transportation including roads, routes, temperature profiles and transport duration as well as on a product basis
- Assessing Vendor data (OQ) for active and passive solutions used in transportation or performing operational qualification (OQ) in collaboration with an external certified laboratory.
- Performing shipping qualification studies (PQ) considering holistic approach on global transportation and replenishment processes
- Working with multiple Sites and CMOs, 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 and periodic review.
Operational and Tactical Accountabilities
- Understands basics of supply chain flow & concepts from long term demand to distribution to the patients (tools, terminology and techniques).
- Understands the importance of accurate and comprehensive master data and GxP rules. At ease using IT tools used in supply chain.
- Working knowledge of GMP/GDP regulations, implementing procedural control frameworks, and experience with audit/inspection protocols.
- Ability to manage the grey zone, balance multiple priorities
- Able to work without direct supervision; able to work under pressure and within an international team environment
Development and Strategical Accountabilities
- Analytic and synthetic approaches to identify optimal solutions to complex system problems.
- Self-directed in defining a problem, identifying root cause & correlations, defining solutions and selecting the most appropriate, and checking the effectiveness of the solution post-implementation
Key stakeholders for liaison
- Internal: All Global Distribution pillars; In-Market Supply Chain, IM and Site Supply Chain Management, Global Quality Management, Regulatory
- External: Logistics Service Providers/Vendors
Skills:
- gdp
- gmp
- supply chain
- distribution logistics
- compliance
Job Title: Global Distribution Compliance Expert
Location: Braine-l'Alleud, Belgium
Rate/Salary: EUR Hourly
Job Type: Contract
Trading as Aerotek. Allegis Group Limited, Maxis 2, Western Road, Bracknell, RG12 1RT, United Kingdom. No. . Allegis Group Limited operates as an Employment Business and Employment Agency as set out in the Conduct of Employment Agencies and Employment Businesses Regulations 2003. Aerotek is a company within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Aston Carter, EASi, Talentis Solutions, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at our website.
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