In this position you are responsible for all QP related matters. This mean you ensure that each GMP batch is produced and analysed in accordance with the cGMP guidelines and European directives 2001/83/EC. You are responsible for the EU QP batch certification as per Annex 16 and 13. You will release or reject products, ensuring that each finished medicinal product batch has been manufactured in accordance with EU-GMP (or equivalent to EU-GMP). Also, provide certifications for product release or sale on the EU market and maintain the quality management reviews, annual product reports, change controls, self-inspections, CAPAs, deviations, etc. Ensuring certifications are recorded in a register or equivalent document is one of your key tasks. You are also responsible for continuously improving and maintaining the quality system to ensure compliance with the applicable GMP/GCP regulations and local requirements. Planning, directing, and monitoring all employees involved for the necessary guidelines/SOP training courses also belong to your key activities.