Distribution Compliance Specialist

  • Location: Braine l'Alleud
  • Type: Contracting
  • Job #19993

Distribution Compliance Specialist

Brabant Wallon – Contracting

#GDP #ISTA #ISPE

Our partner is looking for a Distribution Compliance Specialist to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines

What are your responsibilities?

  • General
  • Act as subject matter expert (SME) for documenting "shipping qualification" protocols and reports in reference with thermal and mechanical aspects for packaging systems used within logistics.
  • Provide SME support and training to key stakeholders including markets, CMO's, Quality teams etc.
  • Assure pro-active risk management by deploying comprehensive risk assessments for key areas and make sure response plans are followed.
  • Drive cost improvement of shipping systems and implement new shipping systems solutions in relation with the business needs.
  • Ensure audit readiness including GDP inspection (MHRA, FDA, country specific ANVISA,…) and internal and external audit (Customers, Corporate,…) readiness at all times and act as SME during these inspections and audits.
  • Shipping qualification accountabilities
  • Drive and coordinate the product shipping risk analysis, mechanical and thermal shipping qualification, and transport conditions assessment per product.
  • Drive and coordinate shipping qualification of passive and active shipping systems for new products launches or new businesses (new primary, secondary or tertiary packaging or new product flows DS, DP and FG.
  • Cold chain accountabilities
  • Translate relevant regulatory requirements (GDP, USP, ASTM, ISO, ….) into a global strategy for Cold Chain management within our partner’s company
  • Implement the global strategy for Cold Chain management. Revise and maintain standard operating procedures in collaboration with local stakeholders.

Who are you?

  • You hold a master’s degree in Supply Chain or equivalent by experience
  • You have at least 5 years relevant and working experience in international pharmaceutical logistics management and/or supply chain expertise (knowledge of GMP)
  • You have an excellent understanding of GDP (European and International), product mechanical and thermal shipping solution guidelines (ISTA, ASTM, ISPE, ..)
  • You are able to work without direct supervision,  able to work under pressure within an international team environment
  • You are fluent in English

Our offer?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We invite you to apply!

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