QA Operational readiness Officer
il y a 3 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 7 heures
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 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
2440 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 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 Csv Contractor
il y a 2 jours
Geel, Belgique J&J Temps plein**QA CSV Contractor / Quality Assurance Computer System Validation** **Location**:Geel, Belgium - Hybrid working - 3 days a week on site **Duration**: 12 months **Hours**: 40 hours Imagine your next project working as a QA CSV Contractor for Johnson & Johnson. Support the QA Engineering department at J&J Geel in assuring that all CSV related regulatory...
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QA Director Commercial Api
il y a 2 semaines
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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QA Director Commercial Api
il y a 2 jours
Geel, Belgique Johnson & Johnson Temps plein**Function** - Quality **Sub function** - Quality Assurance **Category** - Director, Quality Assurance (PL9) **Location** - Geel / Belgium **Date posted** - May 28 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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QA Csv
il y a 3 jours
Geel, Belgique J&J Temps plein**QA CSV / Quality Assurance Computer System Validation** **Location**:Geel, Belgium - Hybrid working - 3 days a week on site **Duration**: 12 months **Hours**: 40 hours Imagine your next project working as a QA CSV Contractor for Johnson & Johnson. Support the QA Engineering department at J&J Geel in assuring that all CSV related regulatory and...
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Customer Service Officer
il y a 3 jours
Geel, Belgique Group-GTS Temps plein**Over Group-GTS** Bij Group-GTS zijn we gepassioneerd om een toonaangevende rol te vervullen in de transport - en logistieke sector. Met ons uitgebreide wagenpark en onze moderne magazijnfaciliteiten in de haven van Antwerpen streven we ernaar om onze klanten de beste service te bieden. Onze medewerkers maken gebruik van geavanceerde technologieën om...
