QA Specialist

Breda, reference 2025-02071

Job description

Only candidates living within a commutable distance to Breda and able to start quickly will be considered.

Our client is looking for a QA Specialist who will play a key role in ensuring GMP compliance across equipment, automation, and information systems. In this role, you will support validation activities, guide operational teams on quality requirements, and act as a subject-matter expert in core QA processes such as change control and quality risk management.

What You’ll Do

• Provide QA support and oversight for validation of equipment, automation, and information systems.
• Review and approve validation documentation, ensuring compliance with Corporate, Site, and Regulatory standards.
• Align on validation strategies together with PD, Maintenance & Engineering, and IS teams, providing clear guidance on design, characterization, and validation activities.
• Review and approve equipment-related changes (e.g., parameter updates, like-for-like assessments).
• Review and approve changes to M&E procedures, including changeover processes and maintenance activities
• Manage device-related responsibilities and ensure alignment with all relevant GMP regulations.
• Represent QA in QRM activities such as pFMEA, QRAES, and computer system compliance.
• Ensure site-level Quality Risk activities align with corporate policies and strategy.
• Review and assess QRM reports.
• Perform final QA review of technical change controls, ensuring stakeholder assessments are complete and accurately documented
• Act as QA Subject Matter Expert, collecting input from multiple QA areas to provide a complete QA assessment for technical changes.

Requirements

Requirements:

• Master degree in Engineering, Pharmaceutical sciences, Process Technology or equivalent
• 5-8 years of professional experience in GMP environment
• Relevant experience in Equipment and Automation Validation
• Proven experience with GMP, equipment and automation/IS validation, computer compliance (Annex 11, Part 11).
• Proven experience with risk management tools such as FMEA, etc.
• Proven experience with statistical tools to support e.g. sampling plans and hypothesis testing.

Working conditions

• A challenging work environment with excellent career development programs.
• Hybrid position, but at least 3 times per week on site in Breda.
• For this role, the company offers a competitive salary package.
• Reimbursement of travel expenses is dependable on travel distance.
• The contract will be through Undutchables.

Work location

Breda

Company description

Our client is an international market leader in the pharmaceutical industry – focused on transforming science and biotechnology into therapies that have the power to restore health or save lives. The patients are the main priority at all times. This USA founded organization holds a large site in Breda, where produced medicines are labeled, stored and shipped worldwide, to more than 75 countries. The staff in Breda works on supply chain processes, engineering, clinical research, marketing and sales on a daily basis. The company culture is dynamic and fast paced, with a strong international character.

Good to know

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Recruiter contact

Kelsey Persch, Eindhoven
kelsey.persch@undutchables.nl
+31(0)6-34154093