Specialist Technical QA

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.

As a Specialist in our Technical QA Team, you will play a pivotal role in ensuring the highest standards of quality across process validation, quality risk management, and quality engineering. Collaborating closely with our engineering, maintenance, IT and automation teams, you will be instrumental in guaranteeing that any process changes adhere to corporate, site, and regulatory requirements. Your responsibilities extend in providing guidance to our manufacturing teams on technical issues, ensuring a thorough comprehension and adherence to quality policies, standards, and procedures.

Let’s do this. Let’s change the world. In this vital role, you will:

• Collaborate on strategy development, offering guidance on design, characterization, and validation in coordination with the engineering, maintenance, and automation teams.
• Review and approve validation documentation and changes to equipment and procedures, encompassing parameter adjustments, like-for-like assessments, changeover processes, and maintenance activities.
• Act as the representative of QA in Quality Risk Management activities, ensuring alignment with corporate policies such as pFMEA, QRAES, and Computer system compliance.
• Serve as a QA expert, gathering input from various functional areas to conduct comprehensive assessments for technical changes.
• Manage device responsibilities meticulously, ensuring strict alignment with Good Manufacturing Practice (GMP) regulations.

Win

What we expect of you

Join a company that doesn't just meet industry standards but sets them. As a quality professional, bring your unique qualifications to the table:

• Master degree or equivalent experience in Engineering, Pharmaceutical sciences, Process Technology.
• 5-8 years of professional experience in GMP environment
• Proven experience in Equipment and Automation Validation
• Solid understanding of GMP, equipment and automation/IS validation, computer compliance (Annex 11, Part 11).
• Experience with risk management tools such as FMEA, etc.
• Skilled in statistical tools to support https://e.g. sampling plans and hypothesis testing.

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 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.

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