For Amgen Breda, we are looking for a skilled 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.

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.
  • Act as QA Subject Matter Expert during change implementation.
  • 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.

Key Competencies

• 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.