Specialist Distribution Compliance

작업 내용

Specialist Distribution Compliance

Brabant Wallon

#Distribution #Risk #Design #pharmaceutical

Our partner is looking for a Specialist Distribution Complianceto join its team. This international company is well known for the research, the development, and the commercialization of its pharmaceutical products.

Your responsibilities?

• Assure Distribution compliance using best practices in Risk Management
• Comply with GDP regulations
• Develop and safeguard relevant procedures and internal controls
• Spread and deploy methods to proactively manage risk
• Serve patient needs
• Rapid response to distribution compliance related supply interruptions
• Strategize for innovation to facilitate delivery and increase speed
• Protect the company reputation
• Build awareness to integrate GREEN into our logistics/distribution operations
• Help deliver on the company GREEN objectives
• Project‘s company reputation to ensure access to the best opportunities that can help serve patients’ needs
• Drive business value
• Adopt a continuous improvement mindset
• Transparent risk-based decision making
• 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.
• 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 the company.
• Implement the global strategy for Cold Chain management. Revise and maintain standard operating procedures in collaboration with local stakeholders.

Your profile?

• You have at least 5 years relevant and working experience in international pharmaceutical logistics management and/or supply chain expertise with excellent understanding of GDP (European and International), product mechanical and thermal shipping solution guidelines (ISTA, ASTM, ISPE, ..)
• 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

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.

Interested? Do not wait any longer and send you resume: marie.defruit@jeffersonwells.be