Specialist 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 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.
What you will do
Our Site Quality Assurance team has a vital impact on our mission to serve patients. They ensure the quality of our medicines throughout the manufacturing process, supply chain, and product life cycle. Roughly 40 quality professionals in the Netherlands work together to deliver the best solutions to the market and to our patients. The role of Qualified Person is crucial in ensuring the release of investigational and commercial drug product batches aligns with the clinical trial authorization, marketing authorization and good manufacturing practices. You'll provide guidance to maintain top-level quality standards on the shop floor for Production, Maintenance & Engineering, and Quality staff.
Each day will offer intellectual challenges, including non-standard tasks. Packaging operations in our Breda site range from manual to highly automated processes for clinical and commercial medicines, applying state of the art digital and innovative technologies. You'll be at the forefront of projects driving continuous improvement, shaping the future of quality assurance, while advancing our digital and lean mindset. Join us in elevating patient care through unwavering quality commitment. Quality is the core of our business, and this is your chance to thrive!
Let’s do this. Let’s change the world. In this vital role, you will:
- Partner with production, supply chain and engineering staff in providing guidance for quality related matters and the establishment of quality standards and requirements.
- Support a series of projects, ranging from Continuous Improvement initiatives to larger capital investment projects such as introduction of new products and packaging lines
- Own, review and approve production and plant QA related documents (e.g. SOPs, Forms, Training, Risk Assessments, etc).
- Review and approve deviations and CAPA, initiate and own as needed.
- Perform impact assessment as part of change controls impacting production or QA processes.
- Review and approve test protocols before use in production.
- Participate in internal audits and lead as appropriate.
- Participate in regulatory inspections.
- Assist in development and delivery of GMP training for QA and production staff.
- Perform batch release activities.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The quality 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 / or 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.
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. Therefore, Amgen is recognized as World's Best Workplace 2021 ©.
- 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.