Responsable Person

The RP is responsible for safeguarding product users against potential hazards arising from poor distribution practices – as a result, e.g., of purchasing suspect products, poor storage or failure to establish the bona fides of purchasers.

WHAT ARE YOUR RESPONSIBILITIES?

  • Focus on the management of the authorised activities and the accuracy and quality of the records
  • Ensuring that initial and continuous training programs are implemented and maintained
  • Ensuring that Third Parties and customers are approved
  • Approving any sub-contracted activities which may impact GDP
  • Approving any returns to saleable stock
  • Delegate his/her responsibilities when absent to ensure permanent availability to health authorities and keep appropriate records related to any delegation
  • Deciding on the final disposition of the returned, rejected, recalled or falsified products in coordination with QP
  • Ensuring that any additional requirements imposed on certain products by national law are adhered to
  • Ensure Conditions of WDA are met
  • Compliance with GDP and keep up to date with the GDP requirements
  • Ensure the inventory system requires the product storage conditions before accepting it
  • Perform gap analysis with the GDP requirements
  • Conduct routine self-inspection to confirm compliance

WHO ARE WE LOOKING FOR?

  • Storage conditions/requirements for different types of medicinal products
  • Basic understanding of degradation pathways and stability profiles of medicinal products
  • GDP legislation and relevant guidance
  • Requirements for storage facilities, temperature control and monitoring programmes, including mapping and qualification
  • Quality Management Systems and how to manage these effectively
  • Handling of returns/complaints/recalls
  • Risks associated with Falsified Medicines
  • Expectations of a robust Quality Agreement
  • Experience of picking /packing procedures and FEFO (First Expiry, First Out) principles
  • Handling complaints and customer queries
  • Active involvement in the GDP Regulatory Inspections
  • Conducted internal audits to monitor the Quality
  • Management System (QMS) and preferably also external audits covering the various stages in the distribution process
  • Creating/maintaining/auditing the documentation and records involved to ensure compliance with GDP
  • Autonomy – ability to take actions when necessary and take responsibility
  • Management and leadership skills

WHAT DOES QBD OFFER YOU?

  • A monthly wage, car, fuel card, (super fast) bicycle, insurance package, meal vouchers, etc.

But most of all…

  • Working for the Flemish Young Entrepreneur of 2019!
  • A flat organization in the broadest sense of the word
  • An increase in your IQ thanks to our extensive training package
  • A hip office with air hockey table
  • More muscle mass through our weekly boot camps
  • 32 vacation days that you wish were fewer (because it's great to work here ? )
  • A job with long term perspectives for further growth
  • In short … We work, we play, we deliver, we are Quality by Design!

Interested? Apply now by sending us your CV and motivation.