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.
Progenika Biopharma is looking for a Quality Assurance Specialist, to join Quality department.
What your responsibilities will be
Manage product complaints.
Analyze complaints, including risk assessment and determination of reportability to Health Authorities.
Conduct and document investigations related to customer complaints.
Create and maintain Quality procedures related to complaints.
Define and follow up on corrective actions arising from complaints.
Perform audits to ensure that cases logged by technicians are correctly classified.
Prepare trend reports and monitor complaints.
Report adverse events to Health Authorities.
Manage product recalls, Field Safety Corrective Actions (FSCA), and Field Safety Notices (FSN) in line with applicable regulations.
Participate in the definition of vigilance system procedures.
Develop post-market plans, procedures, and reports in compliance with applicable regulations.
Actively participate in projects aimed at improving the effectiveness of the Quality System and its operational efficiency.
Participate in external quality audits.
Generate and monitor post-market indicators within the Quality Management System.
Manage temperature excursions in shipments.
Handle documentation required by distributors for shipments.
Participate in the evaluation and qualification process of product and service suppliers, including audits and technical visits.
Draft quality agreements with suppliers.
Actively participate in projects aimed at improving the effectiveness of the Quality System or productivity, ensuring compliance with applicable GMPs (ISO 13485, 21 CFR 820, 21 CFR 600, MDSAP, or others) and internal procedures.
Plan and propose the acquisition of new resources necessary for the proper execution of assigned responsibilities.
Ensure that all documentation related to assigned tasks is always current.
Coordinate and supervise the activities of team members, if applicable.
Support the Head of Department in various tasks to ensure the effectiveness of the Quality System.
Provide user support for the Document Management System (LSQM) and act as a key user for the application.
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).
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.
Schedule:Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).
Flexibility for U Program: Occasionally remote
Benefits package
Contract of Employment: Permanent position
Location: Derio (Bilbao)
Location: SPAIN : España : Derio[[cust_building]]
Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people all over the world.
A leader in essential plasma-derived medicines and transfusion medicine, we develop, produce and provide innovative healthcare services and solutions in more than 110 countries.
Patient needs and our ever-growing knowledge of many chronic, rare and prevalent diseases, sometimes life-threatening, drive our innovation in plasma-based therapies and other biopharmaceuticals to enhance quality of life.
Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology and infectious diseases.
With a workforce of over 23,000 employees in more than 30 countries and regions, we are committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership in the industry. Our work has a positive social and economic impact in the countries where we operate, creating jobs and generating wealth.
People are at the heart of what we do, and we strive to create an inclusive, diverse, fair and equal society. Maintaining and promoting a workforce that reflects this reality leads to enhanced professional relationships and helps us to give our best to patients, donors and customers.
In 2024, Grifols was named one of TIME’s ‘World’s Best Companies’ for the second year in a row, reaffirming our commitment to excellence. We were also recognized by Forbes as one of the "Best Employers for Women 2023," reflecting our dedication to fostering an inclusive and supportive workplace for all.
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