QA Specialist

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. Benefits

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. Application Procedure If you are interested in this vacancy, you can apply by clicking on the button above. By clicking on apply, you agree to our privacy commitment and terms and conditions . Your application will be sent directly to the recruiter in charge. IMPORTANT: if you are not yet registered with Undutchables we kindly ask you to do so. Your information will be handled in the strictest confidence and your CV will not be sent to a company unless you have given prior permission. xjpvoyz Curious about how the recruitment process works within Undutchables, click here to read more.