Reagents Quality Assurace Specialist

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 that foster an inclusive environment.

 

We are looking for a Reagents Quality Assurance Specialist for ensuring the quality of the reagents of Diagnostic Grifols division, dedicated to the design and manufacture of in vitro diagnostic systems for blood typing.

 

What your responsibilities will be

 

• Review and approve product specifications, risk analysis, manufacturing and quality control methods.
• Collaborate in the industrialization and validation of new manufacturing processes or process changes.
• Manage and document investigations of non-conformances arising during manufacturing and quality control of products, as well as CAPA type actions arising from them.
• Manage and evaluate product related change controls.
• Collaborate in the qualification process of analytical equipment and facilities.
• Participate in the approval of raw materials and product packaging.
• Collaborate in the monitoring of on-going stabilities of the products.
• Collaborate in audits of the quality system and external audits to material suppliers.
• Collaborate in the management of the Quality Management System’s procedures.
• Elaboration and evaluation of quality indicators.

 

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 accommodations may be made to enable individuals with disabilities to perform the essential functions).

 

• Bachelor’s degree in Life Science field (Biology, Chemical, etc).
• Minimum 2 years of experience in a similar position within pharma or medical devices sector.
• High knowledge in GMP.
• English: Advanced level.
• High knowledge in MS Office.
• SAP user or similar ERP.
• You have excellent communication skills.
• You have the ability to analyze in an agile and decisive way.
• You are able to expose the issues in a clear and organized way fo