Qa Manual

Open Assessment Technologies; Barcelona; Híbrido; EUR 65.000 - 85.000; Jornada completa

Descripción de la vacante

Grifols is a global healthcare leader seeking an R&D QA Specialist & Auditor to provide quality oversight of SIO pre-clinical activities, ensuring regulatory compliance and supporting audits from Sant Cugat del Vallès.

You will hold a Bachelor’s degree in Health Sciences, 2–5 years in pharma QA or GLP environments, strong GCLP/GMP/GLP knowledge, advanced English, and SAP/DMS experience.

Formación

• Bachelor's degree in Health Sciences-related field.
• 2–5 years of pharma QA experience or in scientific research environments applying GLP.
• Strong knowledge of GCLP, GMP and GLP quality standards and regulatory requirements.
• Advanced English proficiency.
• Advanced user of Microsoft Office with knowledge of QMS, SAP environments and DMS.

Responsabilidades

• Provide quality oversight of SIO pre-clinical activities to ensure regulatory compliance and alignment with QMS.
• Review study documentation and data; perform internal and external audits; oversee vendors and CAPAs, change controls and controlled docs.
• Support development programs through independent QA oversight and risk identification, driving continuous improvement across cross-functional teams.

Conocimientos

Quality Assurance

GxP GLP

GCLP

SAP

DMS

MS Office

Advanced English

Educación

Bachelor's degree in Health Sciences-related field

Herramientas

SAP

Document Management Systems (DMS)

Descripción del empleo

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.

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions).

• 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).

What we offer

It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.

Grifols is an equal opportunity employer.

Schedule

Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).

Contract of Employment

Permanent position

Flexibility for U Program

Hybrid

Location

Sant Cugat del Vallès