Plant QA/QP Specialist — GMP Release & Compliance

Amgen; Netherlands; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Global opportunities

Diverse and inclusive community

Competitive salary + benefits

On-site gym and restaurant

Job summary

Amgen Breda is seeking a Specialist QA/QP (Plant QA) to release finished drug products and ensure compliance with GMP and marketing authorization requirements. You will guide Production, Maintenance & Engineering and QA staff on quality standards and procedures.

You will lead risk analyses, review critical QA documents, and manage deviations, CAPA, and change controls to safeguard product quality. You will also support audits, inspections, and GMP training initiatives.

Qualifications

• Master in Science degree in Pharmacy or equivalent.
• Thorough knowledge of GMP processes and QA requirements.
• Knowledgeable about EU directive 2001/83/EC article 49 (Qualified Person).
• Acquired practical experience in GMP.

Responsibilities

• Partner with production staff in risk analysis and establishing quality limits.
• Review and approve production and plant QA documents (SOPs, forms, training).
• Review and approve deviations and CAPA; initiate and own as needed.
• Perform impact assessments for changes affecting production or QA.
• Review and approve production equipment maintenance work orders.
• Review and approve test protocols before use in production.
• Participate in internal audits and regulatory inspections.

Skills

GMP knowledge

Quality assurance

Regulatory compliance

Written and verbal communication

Education

Master in Science degree in Pharmacy or equivalent

Job description

Amgen Breda is seeking a Specialist QA/QP (Plant QA) to release finished drug products and ensure compliance with GMP and marketing authorization requirements. You will guide Production, Maintenance & Engineering and QA staff on quality standards and procedures.

You will lead risk analyses, review critical QA documents, and manage deviations, CAPA, and change controls to safeguard product quality. You will also support audits, inspections, and GMP training initiatives.