The Amgen Quality team is looking for an experienced Senior Associate with relevant quality / supply chain / compliance experience to support the implementation and execution of Spain and Portugal quality activities across the product portfolio in support of the affiliate commercial business.
This position is based in Barcelona.If you are looking for your next career step within the Quality field and want to be part of our mission - To serve patients - which drives all that we do, apply or get in touch.
Take a look at our career pages to find out more about Amgen Spain.Role overview : Under the leadership of the Senior Manager Quality Assurance and Responsible Person (RP), the successful applicant will help ensure affiliate compliance with Good Distribution Practice (GDP) and the Amgen Quality Management System (QMS) in accordance with applicable regulations.
Responsibilities : Assists with processes and activities to ensure GDP compliance with the Spain and Portugal Distribution activities as local representative and Amgen Quality Management System (QMS), including but not restricted to the following : + Carries out Intake of Product Complaints into the Amgen database and performs follow-up tasks as necessary+ Support customer approval and reapproval process+ Produces metrics for Product Complaints, Distribution Complaints and Deviations / Corrective Actions+ Supports the distribution processes for all Amgen products under the guidance of the RP+ Liaises with third parties providing sub-contracted services to Amgen, e.
g. Logistics Service Providers, Wholesalers, Product Complaint Intake Call Centre under the guidance of the RP+ Supports the RP in ensuring compliance with the Amgen Quality Management System (QMS), including relevant documentation+ Participates in audits and regulatory Inspections in support of the RP, where applicable+ Supports the RP with GDP and Amgen QMS internal assessments and risk assessments+ Assists with delivery of GDP / Product Complaint training and assignment of GDP training to staff, including annual training reviews+ Supports assessment of temperature excursions+ Qualifications and required experience : + Fluency in Spanish and English languages.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win.
Together, we live the Amgen values as we continue advancing science to serve patients.