Role: QA Technical DepartmentLocation: LeónExperience: 1–3 years.Want to find out more?INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialist knowledge and expertise in scientific research, development, manufacturing, sales and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs) and branded pharmaceutical products, adding value to human and animal health.INSUD PHARMA's activities are organised into three synergistic business areas: Industrial (Chemo), Branded (Exeltis) and Biotechnology (mAbxience), with over 9,000 professionals in more than 50 countries, 20 state-of-the-art facilities, 15 specialised R&D; centres, 12 sales offices and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries worldwide.
Todas las habilidades, cualificaciones y experiencia relevantes que necesitará un candidato seleccionado se enumeran en la siguiente descripción.
INSUD PHARMA believes in innovation and sustainable development.General ResponsibilitySuppliers compliance and Management of quality technical agreements in accordance to internal procedures, GMPs rules, Authorities and customers requirements.
EU & US GMP compliance.
Assure compliance of GMP, regulatory and internal standards according to quality policies and applicable requirements within the organization.Specific ResponsibilitiesReview, negotiate and manage Quality Technical Agreements with customers, suppliers & third parties and services.Supplier's qualification management: risk analysis performance, register update, annual audit plan preparation and follow up, evaluation of the documental compliance, approval and certification status follow up, supplier status update on SAP system.Receipt, filling and delivery to customers of quality questionnaires to be filled by QA.ICH Q3D and nitrosamine reports review and managementElaborate and follow-up self-inspections program and conduct self-inspections.Support and exter
📌 Qa Technical Department (Madrid)
🏢 Chemo
📍 Madrid