Global Distribution Compliance – Shipping qualification and Cold chain expert

Looking for a new challenge? Do you want to be part of an international company that brings together the best experts in Life Sciences, IT and Engineering?

Are you interested in strengthening our Life Sciences team as an Global Distribution Compliance - Shipping qualification and Cold chain expert ?

Then be sure to read on!

Organization

At Modis, we prioritize your professional development. By putting your talents and ambitions first, we can offer you projects that inspire, challenge and reward you – all in line with your unique profile. Thanks to our broad network, we can connect you with diverse internal and external careers and projects in Life Sciences. You have options – only settle for the best.

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.

Main responsibilities:

• 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)
• Create, maintain and lead the "shipping qualification" steering committee to harmonize; guide and coordinate the Distribution compliance work and methodology.
• 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.

Requirements

The ideal candidate has a Bachelor’s Degree or a Master’s Defree, an ISTA Certification and at least 5 years of experience in international pharmaceutical logistics management and/or supply chain expertise with excellent understanding of GDP, product mechanical and thermal protection guidelines.

The ideal candidate also has the following competencies:

• 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
• 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

Offer

Why work as a consultant for Modis Life Sciences?

You will receive a permanent contract. Modis is a part of Adecco, one of the Top 5 companies within the ’Great Place to Work’ ranking. At Modis Life Sciences you’re not just a consultant, you are one of a kind. Our HR Talent Managers value Talent and build client-focused solutions with that in mind. They are dedicated to help you boost your career. This by coaching sessions, development centers and performance reviews. Respect and professionalism are at the basis of our job. We are willing to go the extra mile for and with you.

Do you wish to learn more about Modis Life Sciences? Go to https://careers.modisbelgium.be/