QA/QP Specialist — Plant GMP & Compliance

Biopharma Careers; Breda; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Generous total rewards plan

On-site gym

Restaurant with healthy food

Collective health insurance

Job summary

Amgen Breda requires a Specialist QA/QP (Plant QA) to ensure GMP compliance across production activities. You will partner with production staff to assess risks, approve QA documents, and handle deviations, CAPA, and change controls affecting production.

You will lead QA-related projects and participate in internal and regulatory inspections, training, and continuous improvement of GMP processes.

Qualifications

• Master in Science degree in Pharmacy or equivalent.
• GMP knowledge and practical experience.
• Knowledge of EU directive 2001/83/EC article 49 (Qualified Person).
• Experience in Good Manufacturing Practice (GMP).
• Strong communication and collaboration skills with production and technical staff.

Responsibilities

• Partner with production staff in risk analysis and establishing quality limits.
• Review and approve production/plant QA documents (SOPs, Forms, Training).
• Review/approve deviations and CAPA; initiate as needed.

Skills

GMP knowledge

QA documentation

Regulatory communication

Education

Master in Science in Pharmacy

Job description

Amgen Breda requires a Specialist QA/QP (Plant QA) to ensure GMP compliance across production activities. You will partner with production staff to assess risks, approve QA documents, and handle deviations, CAPA, and change controls affecting production.

You will lead QA-related projects and participate in internal and regulatory inspections, training, and continuous improvement of GMP processes.