-
Quality Assurance Manager
2 settimane fa
NonStop Consulting Siena, Italia A tempo pienoQUALITY ASSURANCE MANAGER - AZIENDA BIOTECH · Il nostro cliente è un'azienda biotech ben consolidata con sede e stabilimento produttivo a Siena. · L'azienda si concentra sulla produzione e lo sviluppo di prodotti iniettabili. · Perché candidarsi? · - Opportunità di crescita prof ...
-
Quality Assurance Manager
1 settimana fa
Tn Italy Siena, Italiacol-wideJob Description:QUALITY ASSURANCE MANAGER - AZIENDA BIOTECHIl nostro cliente è un'azienda biotech ben consolidata con sede e stabilimento produttivo a Siena.L'azienda si concentra sulla produzione e lo sviluppo di prodotti iniettabili.Perché candidarsi?- Opportunità di cr ...
-
Quality Assurance Manager
2 settimane fa
Nonstop Consulting Siena, ItaliaQUALITY ASSURANCE MANAGER - AZIENDA BIOTECH Il nostro cliente è un'azienda biotech ben consolidata con sede e stabilimento produttivo a Siena.L'azienda si concentra sulla produzione e lo sviluppo di prodotti iniettabili.Perché candidarsi?- Opportunità di crescita professionale in ...
-
Quality Assurance Manager
3 settimane fa
Tailor&Fox Srl Terranuova Bracciolini, ItaliaPer Società leader nella produzione di componenti per il **settore fotovoltaico**, con sede in provincia di **Arezzo**, stiamo selezionando una figura di: · **QUALITY ASSURANCE MANAGER** · Il/la Candidato/a ideale ha una laurea Triennale o Magistrale in ambito industriale/gestion ...
-
Quality Assurance Manager Accessories and Footwear
3 settimane fa
Ralph Lauren Scandicci, ItaliaPosition Overview · Essential Duties & Responsibilities · La figura sarà inserita all'interno del team Qualità e risponderà al QA Director, e si occuperà del controllo qualità delle produzioni di borse e accessori in pelle e tessuto, gestendo il contatto diretto dei fornitori e o ...
-
Gmp Quality Assurance Specialist
6 giorni fa
Philogen Siena, ItaliaJob Title: GMP QUALITY ASSURANCE SPECIALIST · Department: QA · Philogen S.p.A. is looking for a "GMP Quality Assurance Specialist" who will report to the GMP Quality Assurance Manager and who will give his/her contribution to quality policies in support of Philogen's Quality Sy ...
-
Quality Assurance Specialist – Master Batch Record
1 settimana fa
Gi Group spa Siena, ItaliaQuality Assurance Specialist – Master Batch Record - Monza · Luogo di lavoro: Siena · HiRevo LifeScience è la specializzazione di Gi Group dedicata alla Ricerca e Selezione di profili in ambito Operation, Quality, Regulatory, R&D, Clinical Research e Sales & Marketing dei settor ...
-
quality assurance specialist – master batch record
1 settimana fa
Gi Group spa Siena, ItaliaQUALITY ASSURANCE SPECIALIST – MASTER BATCH RECORD - MONZA - SIENA · Luogo di lavoro: Siena · HiRevo LifeScience e' la specializzazione di Gi Group dedicata alla Ricerca e Selezione di profili in ambito Operation, Quality, Regulatory, R&D, Clinical Research e Sales & Marketing d ...
-
Massimi Sistemi S.R.L. Siena, ItaliaJr. Technical Project Manager, Life-science, Siena Siena , Italy · We are currently seeking a Junior Project Manager to join our operational office in Siena as part of our team expansion efforts. · Are you proactive and results-oriented in your approach?Do you possess excellent ...
-
Internship Infrastructure
1 settimana fa
Massimi Sistemi S.R.L. Siena, Italia StageSHIPInternship Infrastructure & System Integration Siena , Italy · MAASI Enterprises is looking for undergraduates (or students with a limited number of exams to complete) or recent graduates available to carry out a non-curricular internship in the Infrastructure and System Integra ...
-
Junior It/Ot System Integrator
1 settimana fa
Massimi Sistemi S.R.L. Siena, ItaliaJoin our team as a Junior System Integrator at our main office in Siena. This dynamic role provides a stimulating work environment and the chance to grow professionally in a technologically advanced setting. · The successful candidate will contribute to the management and resolut ...
-
Senior It/Ot System Integrator
6 giorni fa
Maasi Enterprises Ltd Siena, ItaliaMAASI Enterprises, a leading consulting firm in the Life Science industry, is looking for a Senior System Integrator to join our team. · The ideal candidate has a proven experience in IT/OT systems integration and is seeking a new exciting challenges in a dynamic and internationa ...
-
Senior It/Ot System Integrator
2 settimane fa
Massimi Sistemi S.R.L. Siena, ItaliaMAASI Enterprises, a leading consulting firm in the Life Science industry, is looking for a Senior System Integrator to join our team. · The ideal candidate has a proven experience in IT/OT systems integration and is seeking a new exciting challenges in a dynamic and internationa ...
-
Technical Leader
3 settimane fa
deltatre Monteriggioni, ItaliaaziendaWe're an end-to-end provider of premium products and services for global sport and media operators. · We push boundaries every day to offer the most reliable, scalable, engaging end-to-end offerings that continually meet and exceed fan expectations and maximise client valu ...
-
Quality Assurance Internship
1 settimana fa
DIESSE Diagnostica Senese Monteriggioni, Italia StageSHIPLo stage verterà sulle tecniche di attività di gestione dei processi aziendali in tema di assicurazione della qualità e di certificazione di un sistema di gestione integrato qualità, ambiente e sicurezza. · Ricerchiamo una risorsa da inserire in stage nella Direzione Quality Assu ...
-
Quality Assurance Internship
2 settimane fa
DIESSE Diagnostica Senese Monteriggioni, Italia StageSHIPLo stage verterà sulle tecniche di attività di gestione dei processi aziendali in tema di assicurazione della qualità e di certificazione di un sistema di gestione integrato qualità, ambiente e sicurezza. · Ricerchiamo una risorsa da inserire in stage nella Direzione Quality Assu ...
-
Global Product Quality Manager
3 giorni fa
ABB Ponticino, ItaliaGlobal Product Quality ManagerTake your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. · At ABB, we have the clear goal of driving diversity and inclusion across all dimens ...
-
Test Engineer
2 giorni fa
Ascom Holding Ag Scandicci, ItaliaJoin Ascom, a global leader in Healthcare ICT and mobile workflow solutions, where we have been driving advancements for over 160 years from our Swiss-based headquarters. Our commitment to revolutionizing the healthcare industry with transformative technology is unwavering, with ...
-
Quality Assurance Junior
1 settimana fa
Openjobmetis S.p.A. Gambassi Terme, ItaliaOpenjobmetis spa, ricerca la figura di Quality Assurance Junior. · **Posizione**: · - pratiche inerenti la Quality assurance; · - Collaborerà con la Quality manager nell'ottenimento delle certificazioni aziendali e del sistema di gestione; · - supporterà nella gestione del contro ...
-
Quality Assurance Specialist Junior
2 settimane fa
Openjobmetis S.p.A. Cavriglia, ItaliaOpenjobmetis SpA, filiale di Montevarchi, ricerca per strutturata realtà operante nel settore medicale, un/ una · **_ · Quality Assurance Specialist junior · - ** · **Posizione**: · Il/la Quality Assurance Specialist junior affiancherà il Quality Manager in tutte le attività coll ...
Clinical Quality Assurance Manager - Siena, Italia - Philogen
Descrizione
Job Title:
CLINICAL QUALITY ASSURANCE MANAGER (GCP)
Department:
Clinical, QA
Philogen S.p.
A., in preparation for the expansion of clinical activities, plans to strengthen the office of clinical quality assurance. On this regard Philogen is looking for a "Clinical Quality Assurance Manager (GCP)".
The position will be responsible to assess compliance with SOPs, GxP, European regulations, local regulations and guidelines, and clinical study protocols.
This position will collaborate with other functions in the Clinical Department.In particular the successful candidate will be responsible to:
Maintain GCP/ICH compliant systems and processes which control the quality of work and clinical trials conducted in Europe and US.Write and/or review clinical SOPs and support continuous process improvements.
Manage training of staff on company procedures, GCP regulations, and documentation systems.Qualify CRO and other vendors related to the clinical activity.
Perform documentation control in the TMF and quality reviews of clinical trial essential documents and associated documentation (including Protocols, Investigator's Brochure, CRFs, etc.) as appropriate.
Perform routine internal System and TMF audits and checks throughout the lifecycle of a trial/program to ensure compliance with internal procedures, as well as regulatory guidelines.
Report significant clinical quality deficiencies and/or risks to upper management and actively participate in solving the issues.Perform clinical site GCP auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, and agency regulations.
Lead role to prepare company and clinical sites for customer audits and regulatory GCP inspections. Participate as Subject Matter Expert during regulatory GCP inspections.The ideal candidate should have:
A good scientific background (ideally Master/ PhD in Biology, Biotechnology, Life Sciences, etc.).Ideally 3-5 years of experience in Clinical Quality oversight (clinical QA experience in the pharmaceutical industry required).A complete understanding and application of principles, concepts and practices of clinical research procedures is required.
A high level of attention to detail.
The ability to work independently, to prioritize her/his own work as well as to prioritize task and coordinate other team members.
Excellent interpersonal skills, ability to work in teams, flexibility in changing tasks and priorities and motivation for new challenges.Job location:
Sovicille, Siena
Interested candidates are kindly asked to send their Curriculum Vitae to the following e-mail address
, specifying the job position of interest authorizing the process of personal data under Italian Legislative Decree 196/03 and General Data Protection EU Regulation (2016/679).
