R&D QA Specialist & Auditor

Grifols; Sant Cugat del Vallès; Híbrido; EUR 40.000 - 60.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work

Descripción de la vacante

Grifols is seeking a QA Specialist & Auditor to join its international team in Sant Cugat del Vallès. You will provide quality oversight of SIO pre-clinical activities, ensuring studies, processes, and documentation meet regulatory requirements and company standards.

You will review study data, conduct audits, and manage deviations, CAPAs, change controls, and documentation. The role supports development programs to ensure integrity of plasma and non-plasma products, with strong English and

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

Quality Assurance experience

GCLP GMP GLP knowledge

QMS concepts

Educación

Bachelor's degree in Health Sciences or related field

Herramientas

SAP environments

Document Management Systems (DMS)

Microsoft Office

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. 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.

We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.

Grifols is an equal opportunity employer.

Schedule:

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

Benefits Package

Contract of Employment: Permanent position

Flexibility for U Program: Hybrid

Location: Sant Cugat del Vallès

www.grifols.com

Location: SPAIN : España : Sant Cugat del Valles:[[cust_building]]

Learn more about Grifols