Our client is is an independent French family-run pharmaceutical companywhich has been growing for several decades thanks to effective and recognized pharmaceutical products. Ther company has extensive expertise in gastroenterology, rheumatology, ENT, general medicine and consumer health solutions. Also they have diversified into dermocosmetics, product lines. With their own production facilities, they are able to control own industrial developments. Our client‘s business plan centres on the talent of their employees. They are a respectful and caring organization that values entrepreneurial spirit, pragmatism and responsibility. All of them work together to grow their laboratories globally
Summary/ Purpose of the position
Tasks and responsibilities of GDP Qualified Person, main point of contact for SÚKL (for GDP activities). Responsibility for the tasks related to the design, implementation and maintenance of CZ and CEA Cluster Quality Management System, mainly CHC areas (GDP, GVP, Regulatory, GCP).
The QP is responsible for safeguarding product users against potential hazards arising from poor distribution practices. The QP should carry out the duties in such a way as to ensure that the company can demonstrate GDP compliance and that public service obligations are met:
- Ensure that the provisions of the license are observed
- Ensure that the operations do not compromise the quality of medicines
- Ensure that a quality management system is implemented and maintained
- Focus on the management of authorised activities and the accuracy and quality of records
- Ensure that initial and continuous training programmes are implemented and maintained
- Coordinate and promptly perform any recall operations for medicinal products
- Ensure that relevant customer complaints are dealt effectively
- Ensure that suppliers and customers are approved
- Approve any subcontracted activities which may have the impact on GDP
- Ensure that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place
- Keep appropriate records of any delegated duties
- Decide on the final disposition of returned, rejected, recalled or falsified products
- Approve any returns to saleable stock
- Ensure that any additional requirements imposed on certain products by national law are adhered to