Madrid, España
Descripción de la vacante
R&D QA Specialist & Auditor en Sant Cugat, España
Grifols
- HíbridoCombinación de oficina y remoto
- Tiempo completoJornada semanal estándar
- ContratoTemporal o freelance
Sant Cugat, España
R&D QA Specialist & Auditor Ubicación: Sant Cugat del Valles, ES Tipo de Contrato: Indefinido tiempo completo Área: Número de solicitud de puesto: 544292 Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding. Help us lead one of the world’s largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That’s why we need R&D QA Specialist & Auditor like you. What your responsibilities will be
- Provide quality oversight of SIO pre-clinical activities to ensure that studies, processes, systems and documentation comply with applicable regulatory requirements, company standards and the R&D Quality System.
- Review of study documentation and data, quality oversight of SIO pre-clinical activities, execution of internal and external audits, qualification and oversight of vendors and management of quality system processes such as deviations, CAPAs, change controls and controlled documentation.
- Support development programs through independent quality oversight and audit activities, identify compliance risks, drive continuous improvement initiatives and provide QA guidance to cross-functional teams to ensure the integrity, reliability, and regulatory acceptability of SIO pre-clinical activities for plasma and non-plasma products.
- Bachelor’s degree in a Health Sciences-related field, such as Biology, Biochemistry, Chemistry, Biomedical Engineering, or a similar discipline.
- You have 2-5 years of experience in the pharmaceutical industry in a similar Quality Assurance (QA) role or within scientific research environments applying GLP regulations.
- Strong knowledge of GCLP, GMP and GLP quality standards and regulatory requirements.
- Advanced English proficiency.
- Advanced user of Microsoft Office tools, including Word, Excel and Outlook, with solid knowledge of Quality Management Systems (QMS), particularly within SAP environments and Document Management Systems (DMS).
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