QA Specialist: Validation, Risk & Compliance Lead

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

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.