QA Specialist

Talentmark; Breda; On-site; EUR 80,000 - 84,000; Full time

Job summary

A leading pharmaceutical company is seeking a QA Specialist (GMP) in Breda, Netherlands. In this role, you will provide quality oversight for equipment and automation validation, ensure compliance with GMP regulations, and collaborate with engineering and operational teams. The ideal candidate will have a Master's degree, 5–8 years of experience in a GMP-regulated environment, and strong experience with equipment and validation processes. This is a full-time position with a gross annual salary of €80,000–€84,000.

Qualifications

• 5–8 years of experience in a GMP-regulated pharmaceutical environment.
• Proven experience with labeling and packaging equipment validation.
• Strong experience with equipment and automation validation.

Responsibilities

• Provide QA oversight for validation of equipment, automation, and information systems.
• Review and approve validation documentation in compliance with GMP and regulatory requirements.
• Support the introduction and validation of labeling and packaging equipment.
• Collaborate with engineering and validation teams to define testing strategies.

Skills

Strong analytical skills

Excellent communication skills in English

Experience with equipment and automation validation

Knowledge of GMP regulations and validation guidelines

Education

Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology

Job description

Overview

We are currently looking for a QA Specialist (GMP) for Amgen in Breda, the Netherlands to support a major pharmaceutical project focused on the introduction of new production lines and packaging equipment. In this role, you will provide quality oversight and guidance for equipment and automation validation activities within a GMP-regulated environment. As a QA Specialist, you will work closely with engineering, validation, and operational teams to ensure that equipment, automation systems, and related processes meet corporate, site, and regulatory quality standards.

Key Responsibilities

• Provide QA oversight for validation of equipment, automation, and information systems


• Review and approve validation documentation in compliance with GMP and regulatory requirements


• Support the introduction and validation of labeling and packaging equipment


• Collaborate with engineering and validation teams to define testing strategies


• Review and approve equipment-related changes and technical change controls


• Participate in quality risk management activities and support quality investigations


• Ensure compliance with internal quality standards, procedures, and regulatory guidelines

Requirements

• Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology, or similar


• 5–8 years of experience in a GMP-regulated pharmaceutical environment


• Strong experience with equipment and automation validation


• Proven experience with labeling and packaging equipment validation (must-have)


• Knowledge of GMP regulations and validation guidelines (e.g., Annex 11 / Part 11)


• Strong analytical skills and ability to work cross-functionally with multiple stakeholders


• Excellent communication skills in English

Additional Information

• Location: Netherlands (onsite presence required). If you don\'t live in the vicinity of Breda and you are not an EU citizen, your application will be ignored.


• Contract: 1-year contract with project scope until 2028


• Full-time (40 hours per week)


• Gross annual salary: 80.000-84.000 euro