Sr Associate Plant QA

Sr Associate Plant QA

Amgen

Breda, Netherlands

What you will do

As Sr Associate Plant QA, you will be working in 3 shift and you will be mainly responsible for providing QA guidance and support to ABR production.

Besides that, you will be performing Quality Pack Checks and Batch Record Reviews of all commercial batches labeled and packed at ABR. Next to that, you will provide support in different QA-related projects/systems.

In this role, you will be in direct contact with a wide range of stakeholders, and you will be responsible for establishing effective working relationships with production operators, production line leads, production shift supervisors, warehouse, maintenance and engineering, technical QA, and the Qualified Person.

Are you ready? Let’s do this. Let’s change the world.

In this vital role, you will:

• Provide daily guidance and support to Production staff regarding compliance with Standard Operating Procedures and Work Instructions.
• Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.
• Review and approve batch production record data entries before production activities take place.
• Perform finished product checks during (commercial) production runs.
• Compile and review batch records for lots assembled, packaged, and labeled at ABR and contract manufacturers in preparation for disposition by QP.
• Review and approve Deviation records.

WIN

What we expect of you:

We are all different, yet we all use our unique contributions to serve patients. The Sr Associate Plant QA professional we seek is a collaborator eye detailed with these qualifications:

• Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience.
• Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.
• Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
• Manufacturing and/or Quality analytical processes and operations.
• Fluent in the English language.