Plant QA Specialist & Qualified Person (GMP)

Amgen; Breda; On-site; EUR 70,000 - 100,000; Full time

Job summary

Amgen Breda is seeking a Specialist QA/QP to release finished drug product lots and ensure compliance with GMP and regulatory requirements. You will guide Production, Maintenance & Engineering and QA staff, reviewing SOPs and deviations while maintaining quality standards.

The role requires a Master in Science in Pharmacy (or equivalent) and strong communication skills to collaborate across global teams. Join Amgen to contribute to medicines delivered worldwide and participate in audits and

Qualifications

• Knowledgeable about GMP, QA and manufacturing processes.
• Ability to communicate effectively with production and technical staff.
• Strong written and verbal communication skills including technical writing.

Responsibilities

• Release Finished drug product lots as Qualified Person following GMP and marketing authorization.
• Provide guidance to Production, Maintenance & Engineering and Quality staff.
• Review and approve SOPs, training, deviations, CAPA and related documents.
• Participate in internal audits and regulatory inspections.
• Lead or assist in investigations and validation activities.

Skills

GMP knowledge

Communication skills

Problem solving

Documentation review

Education

Master in Science degree in Pharmacy or equivalent

Job description

Amgen Breda is seeking a Specialist QA/QP to release finished drug product lots and ensure compliance with GMP and regulatory requirements. You will guide Production, Maintenance & Engineering and QA staff, reviewing SOPs and deviations while maintaining quality standards.

The role requires a Master in Science in Pharmacy (or equivalent) and strong communication skills to collaborate across global teams. Join Amgen to contribute to medicines delivered worldwide and participate in audits and