Packaging Equipment QA Specialist, Breda, Noord-Brabant

About the company
A global pharmaceutical manufacturing organisation operating in a highly regulated Good Manufacturing Practice environment. The site in Breda focuses on the production, testing, and release of medicines and requires strict compliance with global quality and regulatory standards across equipment, systems, and processes.

Role description
The Packaging Equipment QA Specialist role provides quality oversight for validation activities related to equipment, automation, and computerised systems. The position ensures compliance with internal, corporate, and regulatory requirements by reviewing and approving validation documentation, supporting quality risk management, and guiding operational teams. The role acts as a quality subject matter expert within technical change, validation, and engineering-related activities.

Key responsibilities

• Provide QA oversight for validation of equipment, automation, and information systems
• Review and approve validation strategies, protocols, and reports
• Ensure compliance with corporate, site, and regulatory requirements
• Provide guidance to operations, engineering, and automation teams on quality requirements
• Review and approve changes to equipment, including parameter changes and technical assessments
• Review and approve maintenance and engineering procedure changes
• Act as QA representative in quality risk management activities (including risk assessments and failure mode analysis)
• Ensure alignment of site risk management activities with corporate standards
• Perform final review and approval of technical change controls
• Ensure completeness of documentation and cross-functional input in change records
• Provide quality engineering support for investigations and testing strategies
• Support validation and compliance of combination products and devices (where applicable)

• Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology, or equivalent
• 5+ years of experience in a GMP-regulated environment
• Strong experience in packaging equipment, automation, and computer system validation
• Knowledge of Good Manufacturing Practice regulations and computer system compliance (Annex 11, 21 CFR Part 11)
• Experience with quality risk management tools (such as failure mode and effects analysis)
• Experience with statistical tools for validation and sampling strategies
• Strong analytical and problem-solving skills
• Excellent communication and documentation skills
• Ability to work cross-functionally and influence stakeholders
• Strong attention to detail and risk-based decision-making mindset
• Team-oriented and collaborative working style

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