Specialist QA/QP (Plant QA)

Specialist QA/QP (Plant QA)

Amgen

Breda, Netherlands

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

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
• Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to effectively communicate and collaborate with production and technical staff