Specialist Plant QA/Qualified Person

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:

Specialist Plant QA/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

Our Quality Assurance team has a vital impact on our mission to serve patients. They ensure the quality of our medicines throughout the clinical research, supply chain, and product life cycle. We have a team that focuses on Commercial and Clinical products, Manufacturing, Lifecycle Management, Compliance, and Distribution. Roughly 40 quality professionals in the Netherlands work together to deliver the best solutions to the market and to our patients. We are a Biotech company with high-quality standards, and this is embedded in our culture throughout the company.

In this role, you act as a Qualified Person. You are responsible for releasing finished drug product batches while ensuring compliance with the requirements of the marketing authorization and good manufacturing practices. As a Specialist Plant QA, you provide guidance and direction to Production, Maintenance & Engineering, and Quality staff on the shop floor regarding compliance with quality standards and procedures. This role will challenge you intellectually with non-standard QP tasks. With our clinical and commercial packaging operations on-site in Breda, varying from highly manual to highly automated processes, every day will be different. You will represent the quality department in all kinds of projects related to digitalization, automation, continuous improvement, and many others.

Let’s do this. Let’s change the world.

In this vital role, you will :

• Release the labeled and packed products for the different markets that Amgen serves;
• Own, review and approve production and plant QA related documents (e.g. SOPs, Forms, Training);
• Review and approve deviations and CAPA, initiate and own as needed, and you will lead and assist in various investigations as needed;
• Perform impact assessment as part of change controls impacting production or QA processes;
• Review and approve production equipment maintenance work orders/job plans, and test protocols before use in production;
• Perform GMP compliance checks in production;
• Participate in internal audits and lead as appropriate, and in regulatory inspections and partner audits.
• You assist in the development and delivery of GMP training for QA and production staff;
• You lead and participate in Plant QA related projects/global QA initiatives;
• You assist in validation activities as needed including review and approval of validation documents.

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Specialist Plant QA/Qualified Person professional we seek is an effective communicator with these qualifications:

• Master in Science degree in Pharmacy or equivalent;
• Previous experience in processes involved in clinical and commercial manufacturing (GMP), warehousing, supply chain, equipment engineering principles, and validation;
• Knowledgeable and skilled to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person);
• Previous practical experience in Good Manufacturing Practice (GMP) ;
• Ability to problem solve and make scientific risk-based decisions;
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with the ability to effectively communicate and collaborate with production and technical staff.

THRIVE

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 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, vitality program, and a restaurant with healthy food.