Lavori attuali relativi a Associate director/senior manager, quality assurance - Rome - Altro
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Associate Director, Public Affairs
1 settimana fa
Rome, Italia Avanade Spain Sl A tempo pienoThe Associate Director plays a pivotal role as a workstream and team leader, taking ownership of client relationships and ensuring they are managed effectively. In this capacity, the Associate Director oversees client projects by guiding project teams and delegating tasks with precision, ensuring smooth execution and alignment with objectives. Beyond project...
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Associate Director, Public Affairs
6 giorni fa
Rome, Italia Avanade Spain Sl A tempo pienoThe Associate Director plays a pivotal role as a workstream and team leader, taking ownership of client relationships and ensuring they are managed effectively. In this capacity, the Associate Director oversees client projects by guiding project teams and delegating tasks with precision, ensuring smooth execution and alignment with objectives. Beyond project...
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Senior Quality Assurance Engineer
6 giorni fa
Rome, Italia Adecco A tempo pienoLa divisione specializzata Adecco LifeScience ricerca, per conto di nota azienda operante nel settore Medicale, di un/a:Senior Quality Assurance EngineerLa figura avrà la responsabilità di garantire la conformità dei processi e dei prodotti alle normative di riferimento, supportando sia lo sviluppo di nuovi prodotti sia le attività di...
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Associate Project Director
6 giorni fa
Rome, Italia Primevigilance A tempo pienoLatinaEUR 50.000 - giorni faWithin our Consult business we harness our unique combination of leading-edge practical expertise and project delivery consultancy to unlock potential in every project. Our Mobility team is expanding in Europe. We have an exciting opportunity for a Project Manager (Associate Director) to join our Aviation team on a full-time...
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Rome, Italia Hempel A tempo pienoOverview Supplier Qualification and Quality Assurance Senior Inspector for Paul Wurth Italia spa, a company of SMS Group, for the Center of Excellence "Supply Chain Management". Ensure product and process quality compliance throughout the supply chain, adhering to technical, regulatory, and contractual standards. This role oversees supplier qualification,...
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Quality Assurance Associate
6 giorni fa
Rome, Italia MANTU GROUP SA A tempo pienoWho are we? Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60...
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Quality Assurance Associate
6 giorni fa
Rome, Italia MANTU GROUP SA A tempo pienoWho are we?Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60...
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Quality Assurance
2 settimane fa
Rome, Italia Skytechnology SRL A tempo pienoProfiloQuality AssuranceLuogoRoma e provinciaSettore industrialeAerospazio e DifesaResponsabilita` principaliGestione, analisi e revisione di una grande mole di documentazione tecnica.Supporto alle attività di Quality Assurance nei progetti assegnati.Sviluppo progressivo di autonomia nelle attività operative e nei processi di qualità.Requisiti...
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Quality Manager
4 settimane fa
Rome, Italia Alpinestars A tempo pienoAlpinestars is the leading global performance motorsports apparel, protection and footwear manufacturer. For over 60 years the company has been providing the world’s best athletes and motorsports enthusiasts in the pursuit of performance excellence with the most technologically advanced products which fuse protection, performance, innovation and...
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GMP QA Specialist — Pharma Quality Assurance
2 settimane fa
Rome, Italia Adecco A tempo pienoUn'importante azienda del settore farmaceutico cerca un Quality Assurance Specialist a Bergamo. La figura lavorerà a riporto del QA / QP Manager ed avrà diverse responsabilità, tra cui garantire che le attività produttive siano conformi ai requisiti GMP e gestire le attività di controllo qualità. Sono richiesti una Laurea in biologia, farmacia o CTF,...
Associate director/senior manager, quality assurance
16 ore fa
OverviewTFS Health Science is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions.Join Our Team as an Associate Director/Senior Manager, Quality Assurance (GCP Auditor) - hybrid in Warsaw, Poland or home based in Sweden, Italy or Portugal.ResponsibilitiesPrepares, conducts and follows up on all types of internal and external Gx P auditsSupports and provides leadership in clinical audit activities for both internal and external parties to ensure alignment with TFS standards, regulatory requirements, and quality expectationsWorks closely with Business Leads to coordinate appropriate and complete resolution of audit findings/non-compliant issues, quality investigations, etc. in a timely manner, including approval of corrective action and preventive action (CAPA) plans as requiredConducts peer review of audit reportsSupports and guides operational staff in preparing for customer auditsHosts client auditsPrepares investigational sites for regulatory inspections, as requiredGuides operational staff in preparing for inspections including analysing risks and developing inspection readiness strategyActs as a subject matter expert for inspectors and ensuring the Business Unit team members are fully prepared for interactions; provides training/preparation to the backroom support teamManages team during inspectionsHosts and manages regulatory inspections for clients, as requiredQuality Management SystemFacilitates teams from across the company in generating / updating Controlled Documents; driving the process to ensure Controlled Documents are aligned with the regulatory requirements and the applicable standardsSupports staff from across the company to complete accurate and detailed risk assessments and root cause analysis for all Quality Issues, ensure they are completed on time and documentation is always suitable to share with clients as appropriateAssists staff to prepare appropriate and robust CAPA Plans (for Quality Issues), track and manage these through to completion ensuring the CAPAs are completed on the due dateDrive and actively contribute to continuous improvement of the organisation and development of routines that aim to increase quality and improve complianceClient InteractionsAssists with business development of external quality and compliance servicesLeads / attends client visits / client meetings when requiredSupportProvide quality advice and support to internal clients and external clientsLeads clinical non-compliance event investigations and CAPA implementation that may include monitoring non-compliance trends and effectiveness checksIdentifies potential systemic gaps and coordinates with the appropriate stakeholders to ensure timely remediation. As appropriate, escalates issues of critical non-compliance and/or lack of urgency in remediation to the Head of Quality and ComplianceQualificationsUniversity/college degree in a scientific area (Italy: Life Science degree level education is required)Awareness of the clinical trial area in the CRO and/pharma industry, including knowledge of GCP/Gx P regulationsDeep understanding of GCP/Gx P regulations and standards to facilitate the interpretation and impact of findings of internal and external auditsAt least five (5) years' experience in clinical trials, including quality assurance and quality operation experience. CSV knowledge and experience are a plusAdheres to ethical and good clinical practices and the ability to work as part of a team, as well as work independently in a remote workforce environmentExcellent interpersonal and communication skills and the ability to work on multiple projects with competitive timelinesHighly analytical professional with strong attention to detail and respect for the need for accuracy of informationPro-active, recognizing and anticipating issues, addressing problems and developing solutionsGood planning, organisation and problem-solving abilitiesDemonstrated ability to multitask, prioritize, and complete objectivesExcellent oral and written communication skillsFluent in English, both written and verbalAdvanced user of MS Office applications (Outlook, Word, Excel, Power Point)What We OfferWe provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.
