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Global Distribution Compliance Expert

Employer
Actalent
Location
Brussels (Commune) (BE)
Salary
Hourly
Start date
17 Jun 2021
Closing date
17 Jul 2021

Job Details

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.

MAJOR ACCOUNTABILITIES

  • 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, regulatory 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.

COMPETENCIES

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

Company

About Actalent

Actalent connects passion with purpose. Our scalable services and talent solutions drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world.

 

Actalent’s global footprint and flexible delivery models ensure access to specialized talent where and when you need it. We promote consultant engagement through professional development and provide experiences to ensure continuous learning. Our people are the difference.

 

Our expertise spans capabilities in engineering including product and manufacturing, systems and software, construction management, environmental, architecture and civil; and power and utilities. We focus on sciences capabilities in laboratory sciences, healthcare, and clinical research.

 

Actalent is an operating company of Allegis Group, the global leader in talent solutions.

Company info
Website
Telephone
+44 0 1344 383 100
Location
Maxis 2 ,
Western Rd
Bracknell
Berkshire
RG12 1RT
GB

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