Quality & Compliance System Senior Specialist
Salva questo lavoro e mantieni la tua ricerca organizzata
Crea un account gratuito per salvare lavori, creare avvisi e tornare a questa inserzione dalla tua dashboard.
Continuando accetti i nostri Termini & Informativa sulla privacy.
In this role you will lead and optimize the Quality Management System to ensure GMP, FDA and EU compliance across the site. You will partner with cross-functional teams to drive quality improvements, manage inspections, training, and documentation, and report on QMS performance. You will enable a culture of quality and continuous improvement, shaping robust processes for materials, manufacturing, and release specifications. This is a chance to contribute to a globally recognized biopharmaceutical group focused on sustainable health outcomes.
- comprehensive healthcare programs
- work-life balance initiatives
- relocation support
- flexible working arrangements
- remote work options
- Develop and implement QMS processes, procedures, and documentation to meet quality standards
- Monitor and analyze quality data, identify trends, and drive improvement actions
- Prepare periodic QMS performance reports for management
- Collaborate with production, engineering, procurement and other functions to resolve quality issues
- Investigate quality problems, identify root causes, and implement corrective and preventive actions (CAPA)
- Govern and promote a culture of quality and continuous improvement across the site
- Share best practices and ensure activities comply with company procedures
- Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering)
- At least 5 years of pharmaceutical/biopharmaceutical experience in QA, Production, and Process Technology
- Excellent knowledge of EU and FDA pharmaceutical guidelines
- Specialized expertise in GMP compliance improvement processes
- Fluent English (written and spoken)
- Strong teamwork and cross-functional collaboration
- Analytical thinking with ability to assess technical issues and propose shared solutions
- Effective communication and stakeholder management
- QMS development and governance
- Quality data analysis and trend identification
- Root cause analysis and CAPA implementation
Quality & Compliance System Senior Specialist napoli, campania, it
-
napoli, campania, Italia Chiesi Tempo pienoOverview In this role you will lead and optimize the Quality Management System to ensure GMP, FDA and EU compliance across the site. You will partner with cross-functional teams to drive quality improvements, manage inspections, training, and documentation, and report on QMS performance. You will enable a culture of quality and continuous improvement,...
-
Senior QMS
13 ore fa
napoli, campania, Italia Chiesi Tempo pienoChiesi in Napoli, Campania, Italy, seeks a Quality & Compliance System Senior Specialist to lead and optimize the QMS across the site, ensuring GMP, FDA and EU compliance and reporting on performance. You will collaborate with production, engineering and procurement and other functions to drive quality improvements, manage inspections, CAPAs, training, and...
-
napoli, campania, Italia STMicroelectronics Italia Tempo pienoSoftware Quality Assurance Specialist (Quality Champion) What You Will Do Act as the quality reference for one or more software product teams Support teams in tailoring and applying the RFOC software development and quality processes Help define and track quality milestones (reviews, test readiness, release readiness, KPIs, etc.) Contribute to process...
-
napoli, campania, Italia Generali Group Tempo pienoOverview In this role you will support the Investment & Asset Management Compliance team in monitoring regulatory developments and providing advisory services across asset management and banking activities within the Generali Group. You will analyze external regulations, assess their impact on processes and control frameworks, and prepare compliance opinions...
-
Quality Assurance Compliance Specialist
7 giorni fa
napoli, campania, Italia Linkedin Tempo pienoContent Group è una CDMO farmaceutica italiana che offre servizi di sviluppo, produzione, riempimento in asettico e confezionamento di farmaci, dispositivi medici e cosmetici.La preghiamo di leggere attentamente la panoramica e i requisiti per questa opportunità di lavoro riportati di seguito.Grazie a decenni di esperienza consolidata nei settori oftalmico...
-
Quality Assurance Compliance Specialist
7 giorni fa
napoli, campania, Italia Tubilux Pharma Tempo pienoContent Group è una CDMO farmaceutica italiana che offre servizi di sviluppo, produzione, riempimento in asettico e confezionamento di farmaci, dispositivi medici e cosmetici. Grazie a decenni di esperienza consolidata nei settori oftalmico e inalatorio , il Gruppo opera attraverso due eccellenze industriali: C.O.C. Farmaceutici e Tubilux Pharma ,...
-
Quality Assurance Gcp
2 giorni fa
napoli, campania, Italia Phidealive Srl Tempo pienoQuality Assurance (GCP) Specialist Company Description Phidealive S.R.L. is an independent Italian full-service Contract Research Organization (CRO) operating as a Clinical Research Atelier. Unlike large global CROs, we work through a selective, highly tailored model, combining scientific expertise, regulatory rigor and close operational involvement in every...
-
Senior Payroll Specialist, EMEA
1 giorno fa
napoli, campania, Italia Cytiva Tempo pienoBring more to life.At Danaher, our work saves lives. And each of us plays a part. Fueled by our culture of continuous improvement, we turn ideas into impact – innovating at the speed of life.Our 60,000+ associates work across the globe at more than 15 unique businesses within life sciences, diagnostics, and biotechnology.Are you ready to accelerate your...
-
Infrastructure & Network Specialist
10 ore fa
napoli, campania, Italia Aretè & Cocchi Technology Tempo pienoMAGROUP - Magnaghi Aerospace è una realtà internazionale d’eccellenza nel settore aeronautico, con stabilimenti in Italia, Stati Uniti, Brasile, Regno Unito e Canada. Con 90 anni di esperienza, il Gruppo ha prodotto più di 20.000 carrelli d'atterraggio e 40.000 aerostrutture per oltre 10.000 velivoli in tutto il mondo. Per la nostra sede di Napoli ...
-
napoli, campania, Italia Chiesi Tempo pienoOverview You will lead the governance of lifecycle management for Chiesi’s Air/Care and Rare products, partnering with R&D, regulatory, manufacturing and quality teams to drive proactive lifecycle practices. This role anchors governance documentation and ensures regulatory compliance across global markets, while enabling cross-functional collaboration and...
