Specialist QA / QP (Plant QA)

Amgen SA; Breda; On-site; EUR 90,000 - 130,000; Full time

Job summary

Amgen Breda is seeking a Specialist QA/QP (Plant QA) to release finished drug product lots in compliance with marketing authorization and GMP. The role provides guidance to Production, Maintenance & Engineering and QA staff on quality standards and procedures.

You will review deviations, CAPA, change controls, and validation activities while participating in audits and regulatory inspections. This position emphasizes risk assessment, technical leadership, and QA project execution to ensure

Qualifications

• Master’s degree in Pharmacy or equivalent with GMP knowledge.
• Experience with GMP/compliance in manufacturing
• Strong problem-solving and data-driven decision making

Responsibilities

• Act as Qualified Person releasing Finished drug product lots in compliance with MA and GMP.
• Provide guidance to Production, Maintenance & Engineering and Quality staff on quality standards.
• Review and approve deviations, CAPA, and change controls impacting production or QA processes.
• Lead and participate in internal audits and regulatory inspections and plant QA projects.

Skills

Communication skills

Problem solving

GMP knowledge

Education

Master in Science degree in Pharmacy

Job description

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.

Specialist QA/QP (Plant QA)

At Amgen Breda medicines are labelled, assembled, stored and eventually shipped to various countries worldwide. Every day more than 1000 people with 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

In this role you act as a Qualified Person, you are responsible for releasing Finished drug product lots 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 regarding compliance with quality standards and procedures.

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

In this vital role you will:

• You partner with production staff in performing risk analysis and the establishment of quality limits and requirements
• You own, review and approve production and plant QA related documents (e.g. SOPs, Forms, Training)
• You review and approve deviations and CAPA, initiate and own as needed.
• You perform impact assessment as part of change controls impacting production or QA processes
• You review and approve production equipment maintenance work orders
• You review and approve test protocols before use in production
• You perform GMP compliance checks in production
• You participate in internal audits and lead as appropriate
• Participate in regulatory inspections and partner audits
• You assist in development and delivery of GMP training for QA and production staff
• You lead and participate in Plant QA related projects/global QA initiatives as needed
• You lead and assist in various investigations as needed
• 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 sourcing professional we seek is an effective communicator with these qualifications:

• Master in Science degree in Pharmacy or equivalent
• Thorough knowledge of the 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).
• Acquired practical experience in Good Manufacturing Practice (GMP)
• Ability to problem solve and make scientific risk-based decisions

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 (ranking: #8).

• 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 a collective health insurance.
• Focus on vitality with an on-site gym, vitality program and a restaurant with healthy food