Teva Manager Distribution & Commercial Quality TAPI 

Croatia 

742956683

Prigorje Brdovečko (Croatia), Rho (Italy), Debrecen (Hungary), Opava (Czechia)

The person holding this role will support the Global Distribution, Logistics and Commercial Supply Chain to ensure that the distribution and logistics department i.e. transportation, warehousing and storage, function in a way that is in accordance with Good Distribution Practices (GDP) , Good Warehousing and storage Practices ( GWP/GSP) and Good Manufacturing Practices (GMP). This role should ensure that all products manufactured by TAPI are transported, stored and delivered to TAPI’s customers in the most efficient and compliant way without negatively affecting the quality of the product. The person holding this role will be responsible for managing the commercial QA team in Japan and EU and all other work processes of quality management and compliance for distribution centers in accordance with GDP guidelines and TAPI QMS requirements. The person will also be responsible for cGMP compliance by supporting TAPI sites in the network with respect to transportation and warehousing vis-a-vis inspection readiness, execution and follow up of audits, investigations, risk assessments and maintaining the TAPI Quality Management System.

• Create and maintain Good Distribution Practice (GDP) related TAPI policies, SOPs and guidelines.
• Support and drive Logistics development of QMS as part of continuous process improvement.
• Manage logistics service providers and provide support in the quality guidance and GDP development of same together with any relevant training from a quality logistics perspective.
• Prepare shipping qualifications protocols and reports.
• Qualify transportation providers and their maintenance.
• Qualification of transportation containers, logistics flow and warehousing and storage providers.
• Collaborate with relevant regional managers in areas of responsibilities arising from the matrix structure on KPIs and reports for the whole region.
• Perform periodic irregularity reporting and trending, develop annual report on temperature excursions in transportation for the region.
• Perform operational investigation, evaluate and approve CAPA plans for transport and logistics related irregularities
• Provide inspection readiness support to sites related to logistics issues, before, during and after Health Authority inspections.
• Ensure that logistics processes are in compliance with GDP and GMP as applicable to respective country agency regulations and requirements.

• Bachelor's or Master’s Degree in Supply Chain Management, or Logistics or Distribution preferably related to the supply of Pharmaceutical products.
• Minimum of 5 years of experiencein Distribution/Commercial Quality function.
• Advanced practical knowledge of supply chain management of pharmaceuticals.
• Adequate knowledge of local current and upcoming legislation and current Quality best practices*. International experience is an advantage.
• Advanced knowledge of cGMP and GDP requirements for products and process.
• Advanced understanding and insight into the different aspects of quality functions related to QA, Quality Systems, Compliance, Documentation, etc.
• Adequate knowledge of MRP Systems and GMP impacting computer systems, like SAP, LIMS and software platforms typically used by TAPI.
• Ability to understand and execute against TAPI Quality Management System.
• Adequate knowledge of logistics, distribution function and quality systems.
• Advanced experience in working within a matrix environment.
• Advanced communication skills – written and verbal.
• Advanced team working skills.
• Must be able to travel based on business need; up to 30% when critically required (domestic and international)
• Fluent in English – a must

Associate Director Distribution & Commercial Quality

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TAPI will carry out appropriate verification and legally permitted vetting prior to the confirmation of any offer of employment. More information on this verification and vetting will be provided if you reach this stage of the application process.