Specialist QA

Real; Breda; On-site; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Job summary

Amgen Breda is seeking an experienced QA Specialist to support quality oversight activities related to equipment, automation and information systems validation within a GMP-regulated manufacturing environment.

This role collaborates with Engineering, Maintenance, Automation, Manufacturing and Quality teams to ensure validated and compliant operations, in line with corporate standards and regulatory requirements. Excellent communication and problem-solving skills are essential.

Qualifications

• Master's degree in Engineering, Pharmaceutical Sciences, Process Technology or equivalent.
• 5-8 years of experience within a GMP-regulated environment.
• Strong experience in equipment validation, automation validation and computerized systems validation.
• Good understanding of GMP regulations, Annex 11 and FDA 21 CFR Part 11.
• Experience with risk management methodologies such as FMEA.
• Experience supporting validation through statistical and quality tools.

Responsibilities

• Review and approve validation protocols, reports and supporting documentation.
• Provide QA oversight during qualification and validation activities.
• Support validation strategies for equipment, automation and computerized systems.
• Ensure compliance with GMP requirements and corporate standards.
• Represent QA in risk assessment activities including FMEA.
• Review and approve risk assessments and associated documentation.
• Ensure alignment between site quality risk activities and corporate policies.
• Review equipment modifications, configuration updates and process changes.
• Assess maintenance procedures and changes from a quality perspective.
• Support investigations related to equipment and system performance.
• Provide quality guidance to operational and technical teams.
• Support audits and regulatory inspections.
• Contribute to compliance improvements and quality initiatives across the site.

Skills

GMP validation

Quality assurance

Risk management (FMEA)

Equipment validation

Automation validation

Computerized systems validation

Education

Master's degree in Engineering, Pharmaceutical Sciences, Process Technology or equivalent

Job description

Language: English required, Dutch not required

About the Role

For Amgen Breda, we are looking for an experienced QA Specialist to support quality oversight activities related to equipment, automation and information systems validation within a GMP-regulated manufacturing environment.

This position plays a key role in ensuring that systems, equipment and processes comply with corporate quality standards, regulatory requirements and industry best practices. You will collaborate closely with Engineering, Maintenance, Automation, Manufacturing and Quality teams to ensure validated and compliant operations.

Key Responsibilities

Equipment, Process and Automation Validation

• Review and approve validation protocols, reports and supporting documentation.
• Provide QA oversight during qualification and validation activities.
• Support validation strategies for equipment, automation and computerized systems.
• Ensure compliance with GMP requirements and corporate standards.

Quality Risk Management

• Represent QA in risk assessment activities including FMEA and other quality risk processes.
• Review and approve risk assessments and associated documentation.
• Ensure alignment between site quality risk activities and corporate policies.

Change Control

• Review and assess technical change controls.
• Ensure all stakeholder assessments and actions are completed before approval.

Engineering & Maintenance Support

• Review equipment modifications, configuration updates and process changes.
• Assess maintenance procedures and changes from a quality perspective.
• Support investigations related to equipment and system performance.

Compliance & Continuous Improvement

• Provide quality guidance to operational and technical teams.
• Support audits and regulatory inspections.
• Contribute to compliance improvements and quality initiatives across the site.

Requirements

Minimum Qualifications

• Master's degree in Engineering, Pharmaceutical Sciences, Process Technology or equivalent.
• 5-8 years of experience within a GMP-regulated environment.
• Strong experience in equipment validation, automation validation and computerized systems validation.
• Good understanding of GMP regulations, Annex 11 and FDA 21 CFR Part 11.
• Experience with risk management methodologies such as FMEA.
• Experience supporting validation through statistical and quality tools.

Preferred Qualifications

• Experience within the pharmaceutical or biotechnology industry.
• Experience with deviations, CAPAs and change control processes.
• Familiarity with quality engineering methodologies and validation lifecycle management.
• Strong analytical and problem-solving skills.
• Ability to assess complex technical issues using a risk-based approach.
• Excellent communication and stakeholder management skills.
• Strong attention to detail and documentation skills.
• Ability to work independently while managing multiple priorities.
• Team-oriented mindset and collaborative working style.