Amgen zoekt een

Trainee Quality Assurance / Qualified Person

Breda, Netherlands

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 becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us as:

Trainee Quality Assurance / Qualified Person

At Amgen Breda, medicines are labeled, assembled, stored, and eventually shipped to various countries worldwide. Every day more than 1000 people from 38 different nationalities are working on supply chain processes, manufacturing, marketing, and sales of our medicines and clinical research into new medicines.

LIVE

What you will do

Have you graduated with your Master of Science and are you interested in working in the pharmaceutical industry as a Qualified Person? This is a unique opportunity to gain the required experience in an operational environment!

As Trainee QP you will play a vital role in ensuring our medicines are labeled and packed with the highest quality standards. You will guide our production teams and provide quality support during the process. In this role, you will gain experience in batch review and you will support the Qualified Person in the team during the batch release.

By participating in different QA projects and on-the-job training activities to explore the responsibilities of QP, you gain the necessary experience to fulfill the requirements to become a QP yourself in the next 2 – 3 years.

In this vital role, you will :

  • Guide production staff in adhering to Standard Operating Procedures (SOPs) and Work Instructions and increase quality awareness in the teams.
  • Serve as primary quality contact for production queries during critical operations.
  • Review and approve batch production records to ensure regulatory compliance.
  • Perform thorough quality checks on finished products during production runs.
  • Compile and review batch records for QP approval from internal and contract manufacturers.
  • Engage in immersive training to develop expertise in Qualified Person responsibilities.
  • Author and refine operational SOPs and Work Instructions for enhanced efficiency.
  • Contribute to quality and production projects, assist in complex investigations, and support continuous improvement efforts as needed.
  • Work in shifts.

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Trainee QP professional we seek is an analytical thinker with these qualifications:

  • Master in Science degree, preferably in Life Sciences or related field. This is a requirement to become a Qualified Person.
  • Strong interest in Quality Assurance in the pharmaceutical industry and eager to become a future Qualified Person.
  • Typically 1-3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.
  • Affinity with Manufacturing and/or Quality analytical processes and operations.
  • Fluent in the English language.

THRIVE

What you can expect of us

As we work to develop treatments that take care of others, 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 teammates are empowered to bring ideas to the table and act.
  • Generous Total Rewards Plan comprising competitive salary, bonus structure, fixed 13th month, holiday allowance, and collective health insurance.
  • Focus on vitality with an on-site gym, a vitality program, and a restaurant with healthy food.

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