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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 R&D Quality Systems Specialist to join the Quality Assurance department at Grifols SA.
What your responsibilities will be
Quality Management System (QMS)
1. Preparation of technical documentation and procedures related to QMS.
2. Support for the implementation of the QMS application.
3. Conducting user tests and participating in the validation of the QMS.
4. Coordination of training for users of the QMS.
5. Maintenance and implementation of improvements in the QMS application.
Electronic Document Management System (EDMS)
1. Supervision of the document system structure for the pre-clinical groups of Scientific Innovation Office Division (SIO).
2. Coordination of documentation for pre-clinical SIO groups.
3. Drafting of related documentation.
Quality System
1. Monitoring of KPIs related to Quality Management for the pre-clinical SIO groups.
2. Data collection and drafting of the SIO R&D Quality Annual Report.
3. Participation as a quality expert within multidisciplinary groups for new SIO R&D projects.
4. Maintenance of Standard Operating Procedures (SOPs) for Quality.
5. Review technical documentation related to the quality area to develop and implement applicable policies and procedures.
6. Coordination of training for pre-clinical SIO users in the Quality System.
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 Health Sciences or a related field (Biology, Biochemistry, Chemistry, Biomedical Engineering, etc). At least 3 years of experience in the pharmaceutical sector, in a similar QA position or within the field of scientific research having applied GLP regulations. Knowledge of quality regulations and guidelines GLP, GCLP and GMP. Familiarity with ICH quality and research guidelines, as well as ISO standards, is also highly valued. Additional knowledge of FDA, EMA, and other relevant regulatory frameworks will be considered beneficial for the position Advanced level of English. Advanced knowledge of office software: Microsoft Word, Excel, and Outlook, as well as knowledge of Quality Management Information Systems, and Electronic Document Management Systems. Develop collaborative working relationships. Results-oriented and proactive mindset. Willingness to travel (maximum 15%).
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.
Information about Grifols is available at www.grifols.com. If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply!
We look forward to receiving your application!
Grifols is an equal opportunity employer.
Flexibility for U Program: Hybrid
Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h.
Benefits package
Contract of Employment: Permanent position
Location: Sant Cugat del Vallès
www.grifols.com
Location: SPAIN : España : Sant Cugat del Valles:[[cust_building]]
Learn more about Grifols