QA CSV specialist
il y a 5 jours
A key client of BioTalent based in Belgium are looking to onboard a QA CSV specialists for their growing quality assurance unit.This role will be responsible for overseeing all quality assurance activities related to verification (qualification) and validation of computerized systems within the facility.Key responsibilities include:Support projects as a Quality SME for the design, qualification, and validation of computerized systems.Ensure alignment related to priorities with Quality Validation Manager and maintain a strong collaboration with Bio Process Engineering, Validation, IT & Automation and CQV QA specialists.Provide guidance and process support to stakeholders in accordance with GMP regulations and procedures.Provide accurate and timely review and approval of validation documentation (e.g., URS (Technical Specifications), CQV protocols and reports, risk analyses).Responsible for appropriate management of defects / deviations, corrective and preventative actions, and change controls related to CSV scope.Monitor and support the implementation of continuous improvement and process changes, ensuring they are carried out in accordance with GMP and are appropriately assessed regarding any impact on validation.Participate in the maintenance of the QMS as part of the QA teamEnsure escalation of significant/critical quality problems to the appropriate levels of management following the standards set by the QMS.Assist in hosting inspections or audits by regulatory authorities, Global Quality Auditing team, and others as needed.Identify opportunities for process improvements and lead initiatives to enhance quality and efficiency.Ensure a safe and healthy work environment.You will have:Minimum of 5 years' experience in the pharmaceutical industry.Demonstrated experience in Computerised System validationFluent in French and English.IT knowledge : MS Office (Word, Excel, Outlook), Veeva VaultAbility to collaborate and influence across departments and levels.Fluent in French and English.On-site presence required.Reach out for more information.
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CSV Specialist
il y a 5 jours
Brussels, Belgique Nalys Temps pleinCSV Specialist – Catalent Brussels, BelgiumAbout Nalys Nalys is a fast-growing consultancy company specialized in high-tech engineering and life sciences. We partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains. At Nalys, we combine deep expertise with a human-centric approach —...
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CSV Specialist
il y a 5 jours
Brussels, Belgique Nalys Temps pleinCSV Specialist – Catalent📍 Brussels, BelgiumAbout Nalys Nalys is a fast-growing consultancy company specialized in high-tech engineering and life sciences. We partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains. At Nalys, we combine deep expertise with a human-centric approach...
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CSV Specialist
il y a 5 jours
Brussels, Belgique Nalys Temps pleinCSV Specialist – Catalent Brussels, BelgiumAbout Nalys Nalys is a fast-growing consultancy company specialized in high-tech engineering and life sciences. We partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains. At Nalys, we combine deep expertise with a human-centric approach —...
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Global Lead IT Computer System Validation
il y a 2 semaines
Brussels, Belgique Prothya Biosolutions Temps plein🌍 Global Lead – IT Computer System Validation (CSV) Location: Prothya Biosolutions Belgium - Neder-Over-Heembeek (with occasional travel to Amsterdam) Department: IT Reports to: Enterprise IT Architect.Are you a seasoned expert in Computer System Validation (CSV) with a passion for quality, compliance, and innovation in the pharmaceutical industry? At...
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Global Lead IT Computer System Validation
il y a 3 jours
Brussels, Belgique Prothya Biosolutions Temps pleinGlobal Lead – IT Computer System Validation (CSV) Location: Prothya Biosolutions Belgium - Neder-Over-Heembeek (with occasional travel to Amsterdam) Department: IT Reports to: Enterprise IT Architect.Are you a seasoned expert in Computer System Validation (CSV) with a passion for quality, compliance, and innovation in the pharmaceutical industry? At...
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Global Lead IT Computer System Validation
il y a 1 jour
Brussels, Belgique WhatJobs Temps pleinGlobal Talent Manager @ Prothya (part of Accord Healthcare) Location: Prothya Biosolutions Belgium - Neder-Over-Heembeek (with occasional travel to Amsterdam) Department: IT Reports to: Enterprise IT Architect. Are you a seasoned expert in Computer System Validation (CSV) with a passion for quality, compliance, and innovation in the pharmaceutical industry?...
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Technical Business Solutions Specialist
il y a 2 semaines
Brussels, Belgique beBeeFunctional Temps pleinJob Description: You are a detail-oriented professional looking to apply your analytical skills in a business environment. We seek an experienced Functional Analyst to translate complex requirements into precise functional and system specifications.The role requires collaboration with multiple teams, including software engineers, data analysts, and QA...
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QA & Deviations Specialist
il y a 2 semaines
Brussels, Belgique Nalys Temps pleinQuality Consultant – Deviation Management 📍 Brussels Area, BelgiumAbout NalysNalys is a fast-growing consultancy company specialized in high-tech engineering and life sciences. We partner with leading pharmaceutical organizations to deliver expert support and innovative solutions across a wide range of technical domains. At Nalys, we combine deep...
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QA Methodology Specialist
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Brussels, Belgique Eurofins Digital Testing Temps pleinWe are building a dynamic and innovative team where you will have the opportunity to not only grow technically but also personally. As a Test Tool Specialist, you will play a crucial role in ensuring the quality of various products. With a supportive and inclusive work environment, you will have the chance to continuously expand your knowledge, enhance your...
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Packaging Deviations Specialist
il y a 2 semaines
Brussels, Belgique Nalys Temps pleinPackaging Deviation & Continuous Improvement Specialist Brussels, BelgiumAbout NalysNalys is a fast‐growing consultancy company specialised in high‐tech engineering and life sciences. We partner with industry leaders to deliver expert support, innovative solutions, and high‐value technical capabilities. Joining Nalys means becoming part of a dynamic,...
