QA Specialist, Breda, Noord-Brabant

About the company
Our client is a leading organisation in the pharmaceutical and life sciences sector, committed to delivering high-quality products and ensuring compliance with global standards. They foster innovation and excellence across all operations.

Role description
As a QA Specialist, you will provide quality assurance support and oversight for equipment, automation, and information systems validation. You will play a key role in ensuring compliance with GMP standards and regulatory requirements, while guiding operations teams on quality policies and procedures.

Key responsibilities

• Perform QA support and oversight for equipment, automation, and IS validation.
• Review and approve validation documentation to meet corporate, site, and regulatory standards.
• Provide guidance to operations staff on compliance with quality policies and procedures.
• Support quality engineering activities for testing strategies and investigations.
• Participate in Quality Risk Management activities (pFMEA, QRAES, computer system compliance).
• Review and approve changes to equipment and maintenance procedures.
• Manage device and combination product responsibilities in alignment with GMP regulations.
• Perform final review of technical change controls and ensure completeness of QA assessments.

• Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology, or equivalent.
• 3+ years of experience in a GMP environment.
• Strong background in equipment and automation validation.
• Proven knowledge of GMP, computer compliance.
• Experience with risk management tools (e.g., FMEA) and statistical tools for sampling plans and hypothesis testing.
• Excellent analytical, communication, and decision-making skills.
• Ability to work collaboratively and apply a risk-based approach.

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