Specialist Plant QA / Qualified Person

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Job Description - Specialist Plant QA / Qualified Person

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Specialist Plant QA / Qualified Person

Apply remote type Flex Commuter / Hybrid locations Netherlands - Breda time type Full time posted on Posted 2 Days Ago job requisition id R-182257

Career Category

Quality

Job Description

At Amgen, we believe in the power of a shared mission: to serve patients. This drives us to become one of the world’s leading biotechnology companies. As global collaborators, we research, manufacture, and deliver life-changing products to over 10 million patients worldwide. Now, it's your turn to be part of something bigger. Embrace a career you can be proud of 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 42 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. Roughly 40 quality professionals in the Netherlands work together to deliver the best solutions to the market and to our patients.

Become our Specialist Plant QA/Qualified Person and play an important role in ensuring that our produced medicines meet the highest standards and align with regulatory requirements. You'll play a key role in guiding Production, Maintenance & Engineering, and Quality staff to maintain top-level quality products. As part of our team, you'll lead or contribute to projects that drive digital innovation, lean manufacturing and continuous improvement, shaping the future of quality assurance.

Join us in our commitment to quality, and together, let's elevate patient care. This is your chance to thrive in an environment where quality is at the heart of everything we do.

In this vital role, you will :

  • Release labeled and packed products for different markets.
  • Partner with production, supply chain, and engineering staff to establish and guide quality standards and requirements.
  • Own, review, and approve production and quality-related documentation (e.g., SOPs, Forms, Training, Risk Assessments).
  • Review and approve deviations and CAPA, initiate and own as needed.
  • Perform impact assessments as part of change controls impacting production or QA processes.
  • Contribute to and drive continuous improvement projects in cross-functional collaboration.
  • Contribute to and drive digital innovation solutions and applications in cross-functional collaboration.
  • Participate in or lead internal audits and regulatory inspections.
  • Assist in the development and delivery of GMP training for quality and production staff.

WIN

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’s degree in Science.
  • Experience in manufacturing-related Quality Assurance in the pharmaceutical, biotechnology, or medical devices industry.
  • Knowledgeable and skilled to meet the requirements of EU directive 2001/83/EC article 49 (Qualified Person).
  • Practical experience in Good Manufacturing Practice (GMP).
  • Ability to problem-solve and make scientific risk-based decisions.
  • Proficiency in written and verbal communication (including technical writing and presentations) with the ability to effectively 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. Therefore, Amgen is regularly recognized as a Great Place To Work .

  • 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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