QA Specialist
3 dagen geleden
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 DoProvide 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 activitiesManage 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 documentedAct as QA Subject Matter Expert, collecting input from multiple QA areas to provide a complete QA assessment for technical changes.RequirementsRequirements:Master degree in Engineering, Pharmaceutical sciences, Process Technology or equivalent5-8 years of professional experience in GMP environmentRelevant experience in Equipment and Automation ValidationProven 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.BenefitsA 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 ProcedureIf 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. Curious about how the recruitment process works within Undutchables, click here to read more.
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QA Specialist
2 weken geleden
Breda, Noord-Brabant, Nederland Real Voltijd € 55.000 - € 110.000 per jaarQA Specialist(Equipment Validation)Location:Breda regionFull-time:40 hoursDuration:12 MonthsFor a client of ours, we are looking for an experienced QA Specialist with strong expertise in Equipment Validation. This role offers the opportunity to work in a dynamic GMP environment and contribute to critical validation processes for equipment and automation...
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QA Specialist
7 dagen geleden
Breda, Nederland Undutchables VoltijdOnly candidates living within a commutable distance to Breda and able to start quickly will be considered.Heeft u wat nodig is om te slagen? De volgende informatie dient door alle kandidaten zorgvuldig gelezen te worden.Our client is looking for a QA Specialist who will play a key role in ensuring GMP compliance across equipment, automation, and information...
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QA/QC Specialist
6 dagen geleden
Breda, Nederland Undutchables VoltijdOur 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...
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QA Specialist
1 week geleden
Breda, Nederland Undutchables VoltijdOnly 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,...
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QA Specialist
6 dagen geleden
Breda, Nederland Undutchables VoltijdOnly 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,...
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QA Specialist
6 dagen geleden
Breda, Nederland Undutchables VoltijdOnly 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,...
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QA Specialist
3 dagen geleden
Breda, Nederland Undutchables VoltijdOnly 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,...
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QA Specialist
2 dagen geleden
Breda, Nederland Undutchables VoltijdOnly candidates living within a commutable distance to Breda and able to start quickly will be considered.De volgende informatie is bedoeld om potentiële kandidaten een beter inzicht te geven in de vereisten voor deze functie.Our client is looking for a QA Specialist who will play a key role in ensuring GMP compliance across equipment, automation, and...
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QA/QC Specialist
6 dagen geleden
Breda, Nederland Undutchables VoltijdOur 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...
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QA Specialist
3 dagen geleden
Breda, Nederland Undutchables VoltijdOnly candidates living within a commutable distance to Breda and able to start quickly will be considered.De volgende informatie is bedoeld om potentiële kandidaten een beter inzicht te geven in de vereisten voor deze functie.Our client is looking for a QA Specialistwho will play a key role in ensuring GMP compliance across equipment, automation, and...
