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.