QA CSV specialist
il y a 3 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 team Ensure 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 validation Fluent in French and English. IT knowledge : MS Office (Word, Excel, Outlook), Veeva Vault Ability 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 3 semaines
Laeken, Belgique Nalys Temps pleinCSV Specialist – Catalent Brussels, Belgium About 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 3 jours
Laeken, 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 3 jours
Laeken, 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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Packaging Deviations Specialist
il y a 4 semaines
Laeken, Belgique Nalys Temps pleinPackaging Deviation & Continuous Improvement Specialist Brussels, Belgium About Nalys Nalys 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,...
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MES Project Manager
il y a 3 jours
Laeken, Belgique Avertim Temps pleinAbout Avertim Avertim is a uniquely positioned management consulting group that bridges the gap between strategy, technology, and operations. Founded in 2007 and headquartered in Brussels, Avertim has grown into a European consultancy with over 350 consultants across Belgium, France, Germany, and the Netherlands. Our mission: to support leading Life Sciences...
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Packaging Deviation Specialist
il y a 4 jours
Laeken, Belgique fortil Temps pleinQui sommes-nous ? Fortil est un groupe international d'ingénierie et de conseil en technologies, rassemblant plus de 2 500 collaborateurs au sein de 30 agences réparties dans 14 pays. Nous accompagnons les acteurs de l'industrie pharmaceutique sur des projets à forts enjeux de qualité, de performance industrielle et d'amélioration continue, dans un...
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(H/F) Test Automation Specialist
il y a 3 jours
Laeken, Belgique speos Temps pleinSenior Automation Software QA Tester Mission As Senior Automation Software QA Tester, you realize tests according to the department procedure and following test plan. You also suggest improvement for the Testing methodology, and you maintain non regression test cases for client application and products. Responsibilities As Senior Automation Software QA...
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Freelance Quality Control
il y a 4 jours
Laeken, Belgique Amoria Bond Temps pleinFreelance Quality Control & Quality Assurance Consultant Amoria Bond – Belgium (Hybrid / On-site) Sector: Pharmaceutical Location: Belgium Contract: 6–12 months | Extension possible Engagement: Freelance / Contract only (no permanent positions) Key skills: Quality Control, Quality Assurance, GMP, Batch Review, Deviations, CAPA, Pharma Manufacturing,...
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Freelance Quality Control
il y a 4 jours
Laeken, Belgique Amoria Bond Temps pleinFreelance Quality Control & Quality Assurance Consultant Amoria Bond – Belgium (Hybrid / On-site) Sector: Pharmaceutical Location: Belgium Contract: 6–12 months | Extension possible Engagement: Freelance / Contract only (no permanent positions) Key skills: Quality Control, Quality Assurance, GMP, Batch Review, Deviations, CAPA, Pharma Manufacturing,...
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Business Development Executive
il y a 3 semaines
Laeken, Belgique Verbatim Pharma Temps pleinBusiness Development Executive - Clinical / Pharma Logistics We're hiring a commercially sharp, high-energy Business Development Executive to join a fast-growing life sciences logistics organisation supporting clinical trials, pharmaceutical supply chains, and time-critical patient solutions across Europe. Sound like your world? Keep reading. The Company...
