Quality System Technician for distribution activities
5 days ago
Las Rozas de Madrid
Ethypharm is a specialty pharmaceutical company with prominent products in targeted Central Nervous System (CNS) indications, notably severe pain, and opioid dependency, as well as a wide range of high-quality injectable medicines for hospitals and emergency situations. Our Spanish commercial affiliate is based in Madrid with two manufacturing sites located in Bernedo and Casarrubios, which offer a wide range of injectable forms, including flexible plastic bags, liquid vials, lyophilized vials and ampoules. Within the Pharmaceutical Affairs Department, and more specifically the Corporate Pharmaceutical Quality System Department, we are recruiting our new Quality System Technician on a permanent contract. This position, with its rich and varied missions, will enable you to get involved in the quality system activities of our Spanish affiliate, Altan. You will contribute your expertise to the Ethypharm Group, which is expanding rapidly, and to the team, in an international environment. The position will be based at our offices in Madrid (Las Rozas de Madrid/Alcobendas) and will report to the Quality System Supervisor of our Spanish affiliate, Altan. Your missions: Quality system activities : • Participate in the development, implementation and maintenance of the Quality Management System (QMS) of Altan headquarters and distribution site, • Collaborate with the implementation of the quality procedures related to pharmaceutical activities performed in headquarters (GxP) and distribution site (GDP) in compliance with local regulation, international standards and Corporate policies, • Contribute with the maintenance of the Quality System at Altan Headquarters and Distribution site by the monitoring of Quality items: GxP training, deviation, complaints, CAPA, change control, audits, …., • Participate in regulatory inspections from Health Authorities and external audits Distribution Quality activities: • Ensure the continued compliance of distribution activities of Altan in Spain, • Verify the qualification of pharmaceutical suppliers, as well as of the customers to whom products are supplied., • Evaluate and approve, where applicable, the return of medicinal products., • Ensure that the warehouse and equipment are suitably designed and properly maintained, in compliance with validation and maintenance plans., • Environmental control: periodic review of temperature and humidity monitoring in warehouses. Your professional profile: • Pharmacist specialized in Quality, • Minimum of 3 years' experience in Quality in the field of the pharmaceutical industry, ideally related to distribution activities of medicines, • Knowledge of international quality and regulatory standards, • Your rigor and team spirit will enable you to take charge of this position., • You speak English fluently Your personal profile: • Autonomous, with a sense of priorities and team spirit, you will be a key member of the department., • Your interpersonal skills, organizational skills and rigor will enable you to succeed in this position. If you recognize yourself in this description and would like to develop your skills in an engaging position within a dynamic, stimulating, and growing environment, join us!
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