Amgen Specialist QA (Barcelona/Lisbon) in Barcelona, Spain
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that read over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
SPECIALIST QA (Barcelona/Lisbon)
What you will do
In this role you will be responsible to ensure compliance with Quality GMP/GDP) regulations and Amgen procedures as applicable for affiliates; Act as Quality-related interface with customers (e.g. product complaints, recall handling); Provide quality oversight for management of local distribution activities.
The key responsibilities will be:
Develop and maintain local processes and execute the task related to the following areas:
Product Complaint Handling
Customer approval and reapproval
Training on Quality matters
Local batch acceptance
Ensure a follow up on product complaint into the Amgen Complaints Management System
Maintain locally appropriate documentation
Provide oversight for all aspects related to in country product distribution and storage
Support Global Quality Compliance audits at the affiliate
Support Enquiries coming from National Health Authorities
Support on the affiliate self-assessment program
Support in the execution of product recalls and regulatory inspections, including preparation (inspection-readiness)
Represent local affiliate in Int’l Quality Team
Support on supply chain processes as Other local responsibilities e.g. review of transportation documentation, provide the quality oversight of Third parties, assess temperature excursions, returns process, …
May act as deputy for Senior Manager Quality
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
Degree in Chemistry, Pharmacy, Chemical Engineering, Biochemistry, Biotechnology, Pharmaceutical Engineering (or Technology) and Biology or related technological field
Fluency in Spanish/Portuguese and English languages.
Must have strong knowledge and understanding of GDP requirements, cold chain transportation and storage, local regulatory requirements
5 or more years of relevant work experience within the pharmaceutical industry
Autonomy to work under minimal direction and be able to be guided by operational and project objectives
Working with others to ensure effective delegation whilst retaining ownership of the outcome and to contribute by ensuring quality of tasks/services provided by self and others
Communication to put across ideas in a clear and concise manner; present a well-structured case or complex information to others
Understands the customer base and is aware of customer requirements
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Equal Opportunity statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.