QA Operational readiness Officer
il y a 2 semaines
Description: The QA Operational Readiness Officer is responsible for ensuring quality readiness, operational excellence and compliance for the successful startup and commissioning of a new production facility. This critical role coordinates quality-related activities during the facility qualification phase, ensuring seamless transition from construction to operational status while maintaining full regulatory compliance and GMP standards. Key Responsibilities Daily Quality Operations: Provide real-time quality support to project teams Review quality event investigations including root cause analysis, CAPAs, and effectiveness checks, ensuring timely completion Escalate critical quality issues to management Review and assess change control requests for quality impact and ensure proper documentation and approval of quality-related changes Conduct routine GEMBA walks Maintain and update quality management system documentation Operational Readiness: Ensure compliance with local and international GMP requirements Support quality readiness plans for the introduction of a new production facility Conduct readiness assessments and gap analyses for quality systems and processes Coordinate cross-functional readiness activities with manufacturing, supply chain, and regulatory teams Follow-up on quality aspects of facility qualification including DQ, IQ, OQ, and PQ protocols and coordinate with engineering teams on quality-critical facility systems (HVAC, water systems, utilities) Support facility design qualification and compliance with regulatory requirements Support regulatory submission activities and quality sections preparation Support pre-approval inspections (PAI) and regulatory authority visits Risk Assessment & Mitigation: Conduct quality risk assessments for new processes and procedures Identify potential quality impacts and develop mitigation strategies Monitor risk indicators and implement preventive measures Required Qualifications At least Bachelor's degree in Life Sciences, Engineering, Quality Management, or related field 4-6 years of experience in pharmaceutical/biotech quality assurance Core Competencies: Strong knowledge of GMP regulations and pharmaceutical quality systems Understanding of risk and change management principles and methodologies Strong analytical and problem-solving abilities Effective communication and stakeholder management skills Attention to detail with strategic thinking capability Understanding of pharmaceutical manufacturing processes and technologies Ability to work with cross-functional teams and external contractors Experience managing multiple priorities in fast-paced environment
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QA Operational readiness Officer
il y a 3 semaines
Geel, Belgique Arcadis Temps pleinDescription: The QA Operational Readiness Officer is responsible for ensuring quality readiness, operational excellence and compliance for the successful startup and commissioning of a new production facility. This critical role coordinates quality-related activities during the facility qualification phase, ensuring seamless transition from construction to...
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QA Operational readiness Officer
il y a 3 semaines
Geel, Belgique Arcadis Temps pleinDescription:The QA Operational Readiness Officer is responsible for ensuring quality readiness, operational excellence and compliance for the successful startup and commissioning of a new production facility. This critical role coordinates quality-related activities during the facility qualification phase, ensuring seamless transition from construction to...
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QA Operational Readiness Officer
il y a 2 semaines
Geel, Belgique R&D Partners Temps pleinJoin our cutting-edge client and help with revolutionising the future of biologics within this quality assurance position!R&D Partners is seeking a QA Operational Readiness Officer to support the successful startup and commissioning of a new production facility. In this role, you will ensure quality readiness, operational excellence, and compliance with...
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QA Operational Readiness Officer
il y a 2 semaines
Geel, Belgique R&D Partners Temps pleinJoin our cutting-edge client and help with revolutionising the future of biologics within this quality assurance position! R&D Partners is seeking a QA Operational Readiness Officer to support the successful startup and commissioning of a new production facility. In this role, you will ensure quality readiness, operational excellence, and compliance with...
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QA Director Commercial Api
il y a 1 semaine
Geel, Belgique Johnson & Johnson Temps plein**Function** - Quality **Sub function** - Quality Assurance **Category** - Director, Quality Assurance (PL9) **Location** - Geel / Belgium **Date posted** - Jun 17 2025 **Requisition number** - R-000067 **Work pattern** - Hybrid Work Description **Job Function**: Quality ** Job Sub Function**: Quality Assurance ** Job Category**: People Leader **...
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Technical Support Officer
il y a 1 semaine
Geel, Belgique BUSINESS & MARKETING IMPROVEMENT Temps pleinBMI Leisure is a successful and profitable scale-up and has acquired a top tier position as a SaaS (Software as a Service) solution provider within the leisure industry. Our all-in-one solution has been recognized as best-in-class for entertainment centers worldwide. We help these centers to optimize their full operational flow across venues, enhance the...
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Quality Assurance Associate
il y a 3 semaines
Geel, Belgique Proclinical Staffing Temps pleinJoin a cutting-edge pharmaceutical team where your precision and passion for quality will help shape the future of life-saving medicines!Proclinical is seeking a Quality Assurance Associate specializing in Qualification and Validation to join a dynamic quality team. In this role, you will play a key part in ensuring equipment, systems, processes, and...
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Quality Assurance Associate
il y a 3 semaines
Geel, Belgique Proclinical Staffing Temps pleinJoin a cutting-edge pharmaceutical team where your precision and passion for quality will help shape the future of life-saving medicines! Proclinical is seeking a Quality Assurance Associate specializing in Qualification and Validation to join a dynamic quality team. In this role, you will play a key part in ensuring equipment, systems, processes, and...
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Quality Manager
il y a 5 jours
Geel, Belgique Robert Walters Temps pleinOur client, a leading metallurgy group is seeking a Quality Manager- Steel cutting Geel to reinforce its Quality team. Working closely with the QHSE Manager, you will guide key quality activities, monitor performance indicators, and act on critical product decisions to ensure the site's overall reliability and consistency.. Some of your responsibilities will...
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Quality Manager
il y a 3 jours
Geel, Belgique WhatJobs Temps pleinOur client, a leading metallurgy group is seeking a Quality Manager- Steel cutting Geel to reinforce its Quality team. Working closely with the QHSE Manager, you will guide key quality activities, monitor performance indicators, and act on critical product decisions to ensure the site's overall reliability and consistency. . Some of your responsibilities...
