Global R&D QA Auditor | Flexible Hours | Permanent

Grifols, S.A; Sant Cugat del Vallès; Presencial; EUR 50.000 - 70.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Permanent position

Descripción de la vacante

Grifols, S.A., a global healthcare company, is seeking an R&D QA Specialist & Auditor to provide quality oversight of SIO pre-clinical activities, ensuring studies, processes and documentation comply with regulatory requirements and Grifols standards.

You will review study documentation, conduct internal and external audits, qualify and oversee vendors, and manage deviations, CAPAs, change controls and controlled documents to support plasma and non-plasma products.

Formación

• Bachelor’s degree in a Health Sciences-related field, such as Biology, Biochemistry, Chemistry, Biomedical Engineering, or a similar discipline.
• 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).

Responsabilidades

• 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.

Conocimientos

Advanced English proficiency

Microsoft Office

SAP environments

DMS

Educación

Bachelor’s degree in Health Sciences-related field

Herramientas

Microsoft Office

SAP

DMS

Descripción del empleo

Grifols, S.A., a global healthcare company, is seeking an R&D QA Specialist & Auditor to provide quality oversight of SIO pre-clinical activities, ensuring studies, processes and documentation comply with regulatory requirements and Grifols standards.

You will review study documentation, conduct internal and external audits, qualify and oversee vendors, and manage deviations, CAPAs, change controls and controlled documents to support plasma and non-plasma products.