Product Quality Assurance Officer – English – Utrecht

Responsibilities/Tasks

The Product Quality Assurance (QA) Officer is responsible to ensure quality compliance in all company projects, and that all product- and manufacturer-related documentation align with the quality requirements set forth in the relevant policies. The QA Officer also supports the QA and Regulatory (QA&R) Manager and works closely with multiple units across the company.

  • Provide inputs on the product prequalification process with the assistance of the QA&R Responsible Pharmacist and manage product dossiers or other technical documentation.
  • Compile product dossiers on diagnostic devices and food intended for medical proposes; keep the dossiers up to date with latest technical documentation/certificates, ensuring proper filing of records related to QA decisions during the product management lifecycle; and ensure accuracy of dossiers received from vendors, working with Product Technical, Product Information Management, Sourcing & Supplier Contracts and Supplier Engagement, Client Services, Logistics
  • Monitor field safety-notices (FSN) and -corrective actions (FSCA) issued by manufacturers, published by regulatory authorities or available on ECRI platform, and liaise with suppliers and internal units to collect additional information and resolve potential safety issues.
  • Assist the QA&R Responsible Pharmacist to populate the knowledge management repository for product quality-related guidelines and legislation for different product categories.
  • Record and update the non-pharmaceutical suppliers QA documentation related to (re)approval and QA information in the SRM tool. Assist the SRM content team in the improvement of the SRM tool.
  • Maintain the item master to ensure that only approved products are procured and supplied, in line with defined QA policy; and work with IT to implement necessary corrective actions to data management systems and to improve QA related features in the ERP system.
  • Contribute to the development and the design of the IT system for collection of product information and ensure QA compliance working with the Product Information Management Unit.
  • Support Client Services and Sourcing & Supplier Contracts Units in defining product eligibility and quality requirements of medical devices and in-vitro diagnostic devices in collaboration with the QA Unit.
  • Support QA-related incidents by gathering information and support QMU on preparing reports on incidents.
  • Assist in the development and revision of QAU-related Standard Operating Procedures and Work Instructions.
  • Support Logistics and 4PL Units in shipment planning and ensuring compliance with local regulatory requirements by providing insights on product characteristics, stability profile, and storage requirements working with the QA&R Responsible Pharmacist.
  • Collaborate with Product Technical, Product Information Management, Sourcing & Supplier Contracts and Supplier Engagement and QA &R Units to streamline catalog management by contributing insights from medical devices and in-vitro diagnostic regulations.
  • Assist in collection of correspondence and documentation of suppliers’ quality auditing process, working with the QA& R Manager.

Requirements

Professional and Technical Knowledge

  • Bachelor’s degree in Healthcare and Life Sciences or other relevant field.
  • 3+ years’ work experience in quality assurance/regulatory affairs in a medical device & diagnostics industry, healthcare organization.
  • Knowledge about Good Manufacturing- and Distribution- Practices, ISO 13485, and other relevant standards.
  • Understanding of the medical device & diagnostics regulatory environment both at international and country level.
  • Knowledge of the international health products market, and specifically of essential diagnostics required for COVID-19, HIV/AIDS, Tuberculosis, and Malaria.
  • Ability to work comfortably with Microsoft Office software, preferably advanced user level of Excel.
  • Willingness and availability to travel, and perform other duties as needed.

Interpersonal skills/Communication

  • Excellent written/verbal communication skills, English fluency required.
  • Strong interpersonal skills with client relations and customer service experience and an ability to work across disciplines and locations.
  • Demonstrated analytical skills; solution oriented with a high sense of quality, attention to detail, accuracy, efficiency, and meeting tight deadlines.

Client Services & Procurement Specialist – Spanish – Utrecht

The Client Services & Procurement Specialist is expected to serve as the client services expert as well as the procurement and order fulfilment expert for assigned product category within the Client Services Unit and utilize vendor technical expertise for various pharmaceutical and non-pharmaceutical products.

The CS Specialist is the first point of contact for order and related communications and is expected to provide customer service excellence to all stakeholders, including other product category teams. The CS Specialist is expected to provide regular status updates on orders and address questions, concerns and/or change requests that the client may have in coordination with Client Services and Strategic Supply Chain Units, project director, and other stakeholders as needed.

The Client Services & Procurement Specialist is also responsible for maintaining data accuracy from the request to the purchase order confirmation from the vendor; and for working with the Logistics Unit to ensure the supply chain is established and executed key performance indicators (KPIs).

SPECIFIC RESPONSIBILITIES:

Client Relationship Management:

  • Provide proactive customer service while acting as primary point of contact for procurement and order fulfilment, including request for quotations,
  • Work collaboratively with internal and external units, vendors, and partner organisations on procurement and order fulfilment issues.
  • Proactively identify procurement and/or order fulfilment activities potentially impacting the project’s ability to perform its duties and advise the necessary stakeholders.
  • Handle procurement and/or order fulfilment related incidents; log incidents into the Incident Management System, provide inputs for incident investigation and contribute to the resolution within incident set timelines.

Procurement and Order Administration:

  • Coordinate and monitor order management with vendors, including responsiveness to quotations, and contribute to the continuous review of vendor’s operational order management performance.
  • Proactively identify issues with day-to-day ordering processes and resolve and/or communicate the issues to management in a timely manner, as needed.
  • Lead the troubleshooting of procurement and/or order-related challenges define and implement corrective action in case of irregularities working closely with the Category Lead.

Administration:

  • Maintain system-related changes required on requisitions, price quotes and/or purchase orders throughout the procurement or order fulfilment process in coordination with client and/ or Sourcing & Procurement, Client Services & Procurement, and Logistics Specialists.
  • Maintain and update the ERP system at an order level to ensure internal data accuracy and external reporting are optimal.
  • Adhere to established procurement policies and standard operating procedures, identify opportunities for continuous improvement, and provide backup coverage as needed.
  • Perform procurement and order fulfilment duties in a transparent and ethical manner.

Requirements

  • Bachelor’s Degree in procurement, public health, or other related area or equivalent experience.
  • Previous client relations or customer service experience required.
  • 3+years of procurement or order fulfillment experience is preferable..
  • Experience with ERP or other supply chain management system is preferred.
  • Experience in the international, public health sector is preferred.
  • Experience working in a developing country a plus.
  • Fluency in English is required.
  • Excellent written/verbal communication and interpersonal skills with strong sense of customer service.
  • Strong organizational skills and ability to perform multiple tasks simultaneously, set priorities, and work in a team with diverse cultural backgrounds.
  • Solution oriented with a high sense of quality, attention to detail, accuracy, efficiency and meeting tight deadlines.
  • Team player who is also able to work independently and handle conflicting priorities while maintaining consistent, quality performance standards.
  • Ability to work comfortably with Microsoft Office software, specifically Word, Excel, and PowerPoint. Preferably advanced user level of Excel.

Client Services & Procurement Specialist – French – Utrecht

The Client Services & Procurement Specialist is expected to serve as the client services expert as well as the procurement and order fulfilment expert for assigned product category within the Client Services Unit and utilize vendor technical expertise for various pharmaceutical and non-pharmaceutical products.

The CS Specialist is the first point of contact for order and related communications and is expected to provide customer service excellence to all stakeholders, including other product category teams. The CS Specialist is expected to provide regular status updates on orders and address questions, concerns and/or change requests that the client may have in coordination with Client Services and Strategic Supply Chain Units, project director, and other stakeholders as needed.

The Client Services & Procurement Specialist is also responsible for maintaining data accuracy from the request to the purchase order confirmation from the vendor; and for working with the Logistics Unit to ensure the supply chain is established and executed key performance indicators (KPIs).

SPECIFIC RESPONSIBILITIES:

Client Relationship Management:

  • Provide proactive customer service while acting as primary point of contact for procurement and order fulfilment, including request for quotations,
  • Work collaboratively with internal and external units, vendors, and partner organisations on procurement and order fulfilment issues.
  • Proactively identify procurement and/or order fulfilment activities potentially impacting the project’s ability to perform its duties and advise the necessary stakeholders.
  • Handle procurement and/or order fulfilment related incidents; log incidents into the Incident Management System, provide inputs for incident investigation and contribute to the resolution within incident set timelines.

Procurement and Order Administration:

  • Coordinate and monitor order management with vendors, including responsiveness to quotations, and contribute to the continuous review of vendor’s operational order management performance.
  • Proactively identify issues with day-to-day ordering processes and resolve and/or communicate the issues to management in a timely manner, as needed.
  • Lead the troubleshooting of procurement and/or order-related challenges define and implement corrective action in case of irregularities working closely with the Category Lead.

Administration:

  • Maintain system-related changes required on requisitions, price quotes and/or purchase orders throughout the procurement or order fulfilment process in coordination with client and/ or Sourcing & Procurement, Client Services & Procurement, and Logistics Specialists.
  • Maintain and update the ERP system at an order level to ensure internal data accuracy and external reporting are optimal.
  • Adhere to established procurement policies and standard operating procedures, identify opportunities for continuous improvement, and provide backup coverage as needed.
  • Perform procurement and order fulfilment duties in a transparent and ethical manner.

Requirements

  • Bachelor’s Degree in procurement, public health, or other related area or equivalent experience.
  • Previous client relations or customer service experience required.
  • 3+years of procurement or order fulfillment experience is preferable..
  • Experience with ERP or other supply chain management system is preferred.
  • Experience in the international, public health sector is preferred.
  • Experience working in a developing country a plus.
  • Fluency in English is required.
  • Excellent written/verbal communication and interpersonal skills with strong sense of customer service.
  • Strong organizational skills and ability to perform multiple tasks simultaneously, set priorities, and work in a team with diverse cultural backgrounds.
  • Solution oriented with a high sense of quality, attention to detail, accuracy, efficiency and meeting tight deadlines.
  • Team player who is also able to work independently and handle conflicting priorities while maintaining consistent, quality performance standards.
  • Ability to work comfortably with Microsoft Office software, specifically Word, Excel, and PowerPoint. Preferably advanced user level of Excel.

Supply Chain Specialist – Russian or French – Utrecht

Main Tasks

The Supply Chain Specialist (SCS) is a member of the Supply Chain Services team and is responsible for the end-to-end supply chain of medicines and health products from requisition to final delivery. The SCS acts as the supply chain expert for a portfolio of assigned countries within a regional team.

  • Order Management: processing orders from the countries or Principal Recipients and converting these orders into purchase orders to be placed on international suppliers.
  • Exportation and Importation: converting supplier purchase orders into shipments and ensuring all necessary exportation and importation documentation is in place.
  • Transportation: arranging pick-up of the orders with selected Logistics Service Providers and overseeing the pick-up, transportation and delivery of shipments at the Principal Recipients’ chosen point of delivery, e.g. port of entry, central medical store.
  • Customer Service: ensuring the Global Fund and its Principal Recipients are provided excellent customer service with timely updates on orders and shipments.
  • Performance Management: executing order management and transportation within agreed-upon lead times to ensure the organisation meets its KPIs with its clients.
  • Data Management: ensuring operational and performance data is logged on a timely basis, in full and without errors.
  • Quality Management: ensuring goods are ordered and transported as per quality standards and that work is executed as per ISO-certified processes, SOPs and work instructions.
  • Continuous Improvement: actively contributing to the organization’s commitment to innovation by identifying opportunities for improvement in the supply chain.

Requirements

  • Bachelor’s Degree in logistics, management, public health, business or other related area or equivalent experience.
  • A minimum of 2 years’ experience in in a procurement and/or Supply Chain and/or logistic role.
  • Fluency in English.
  • Fluency in Russian or French.
  • Experience with ERP or other supply chain management systems.
  • IT-proficient, with experience in Microsoft Office.
  • Excellent written and verbal communication.

Behavioral competencies

  • Strong organizational skills and ability to perform multiple tasks simultaneously, set priorities and work in a team with diverse cultural backgrounds.
  • Solution-oriented with a high sense of quality, attention to detail, accuracy, efficiency and meeting tight deadlines.
  • Dynamic and solution-orientated.
  • Can work independently but also as a team player.

Export Desk Representative – Nijmegen

Our client is an international leader in global IT field. They are looking for a self motivated, proactive go getter to work as their Export Desk representative. In this role, you will be responsible for the company’s global logistics services around IT projects and hardware contracts. You will become a pivotal part of a very vibrant and successful international team.

 

Main Tasks

  • Supporting the sales teams in finding and facilitating the best solution to move IT hardware globally.
  • Managing the shipping process from start to finish.
  • Monitoring outgoing and incoming shipments.
  • Ensuring that communication, both internally and externally, is timely and accurate throughout all phases of the transport process.
  • Striving for continuous improvement of work methods, processes, routes, and communication flows.
  • Advising sales teams on available routes, shipping costs, duties & taxes, and custom requirements.
  • Preparing import and export documents.
  • Organizing global transport: arranging pick-ups, booking international flights.
  • Managing the worldwide partners’ network: identifying new contacts for custom clearance procedures, developing and maintaining the relationship with them to get them to join the company’s network.
  • Tracking, recording, and updating transport information in CRM system.
  • Providing shipment status updates to parties involved.
  • Acting on market changes and identifying alternative routes or ad hoc solutions.
  • Improving logistics processes and routes.
  • Providing reports on export desk-related activities.

 

Requirements

  • Bachelor (or Master) diploma.
  • Experience with import/export/logistics and/or international business is a plus.
  • 2 years of work experience as a project manager or similar position.
  • You are analytical, detail-oriented, pragmatic and with a great set of organizational skills!
  • You like to untangle issues and do not let go until the problem is solved.
  • You understand the need for rules and procedures but can also think outside the box.
  • You are a real team player! You are driven, proactive, accountable, and cooperative.
  • You have excellent English communication skills, both verbally and written.

Export Administrator with Dutch – Amersfoort

Our international client who are a global leader in technology are looking for a new addition to their dynamic team based in Amersfoort. This person will be interacting with different departments within the company from Sales, Operations to Accounting and be the first point of contact for freight forwarders.

Main Tasks

  • Prepare commercial invoices and packing lists for international sales orders.
  • Data entry to the customs declaration system.
  • Maintain contact with freight forwarders on shipments for pickup.
  • Is the primary contact for customs inspections of identified shipments
  • Provide required details to sales department
  • Other duties as required

Requirements

  • Knowledge and expertise of international shipping requirements, restrictions, customs declarations, and the necessary accompanying documentation is essential.
  • Must be familiar with shipping processing including UPS, FedEx, TNT, and other on-line web-based shipping applications.
  • Experienced with Microsoft Office products, Excel, Word.
  • Good verbal and written skills in English and Dutch are required. Must be able to follow verbal and written procedures with minimal supervision.
  • This position reports directly to the Logistics Administration Supervisor.