Clinical Quality Assurance Specialist
3 settimane fa
Philogen is looking for a “Clinical Quality Assurance Specialist (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 MSc. 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 English language, both written and spoken. 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. Location : Siena (SI) - ItalyWe invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree 196 / 2003. Our recruitment adheres to the provisions of Legislative Decree 198 / 2006, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief. #J-18808-Ljbffr
-
GMP Quality Assurance Specialist
1 settimana fa
Toscana, Italia Philogen S.p.A. A tempo pienoDirect message the job poster from Philogen S.p.A. GMP Quality Assurance Specialist 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 System. In particular the successful candidate will be...
-
Quality Assurance Specialist
2 settimane fa
Toscana, Italia PQE Group A tempo pienoSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device? PQE Group è affermata in questo settore dal 1998, garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe.Lavorare in una realtà di consulenza come PQE Group ti...
-
Quality Assurance Specialist
2 settimane fa
Toscana, Italia PQE Group A tempo pienoSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device? PQE Group è affermata in questo settore dal 1998, garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe.Lavorare in una realtà di consulenza come PQE Group ti...
-
Quality Assurance Specialist
4 settimane fa
Toscana, Italia PQE Group A tempo pienoSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device? PQE Group è affermata in questo settore dal 1998, garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe. Lavorare in una realtà di consulenza come PQE Group ti darà:...
-
Quality Assurance Specialist
2 settimane fa
toscana, Italia PQE Group A tempo pienoSei pronto per entrare a far parte di una società di consulenza leader mondiale nell'industria farmaceutica e dei Medical Device ? PQE Group è affermata in questo settore dal 1998 , garantendo una presenza internazionale grazie alle 45 filiali e i 2000 dipendenti in Europa, Asia e nelle Americhe. Lavorare in una realtà di consulenza come PQE Group ti...
-
Product Quality Assurance Specialist
2 settimane fa
Toscana, Italia Hitachi Rail A tempo pienoHitachi Rail is looking for an enthusiastic self‑motivated Product Quality Assurance Specialist who thrives in a fast‑paced environment. The successful candidate is comfortable performing a wide range of tasks from administrative to strategic. The position is based in Pistoia, Italy. Accountabilities Product Quality Assurance Specialist : Overviews...
-
Quality Assurance
4 settimane fa
Toscana, Italia Taskforce A tempo pienoOverview We are looking for a Quality Assurance to oversee and coordinate cross-functional activities, ensuring the highest quality standards across production processes. The role will lead a small team, driving strategic actions and projects to improve quality performance, while collaborating closely with plant leadership, production, engineering, and...
-
Quality Assurance
4 settimane fa
Toscana, Italia Taskforce A tempo pienoWe are looking for a Quality Control / Quality Assurance profile to oversee and coordinate cross-functional activities, ensuring the highest quality standards across production processes. The role will drive strategic actions and projects to improve quality performance, while collaborating closely with plant leadership, production, engineering, and...
-
Product Quality Assurance Specialist
2 settimane fa
Toscana, Italia Manpower PISTOIA GALVANI A tempo pienoManpowerGroup è una multinazionale leader mondiale nelle soluzioni innovative per la gestione delle risorse umane. Fondata nel 1948, aiuta le organizzazioni a reperire, valutare, sviluppare e gestire talenti, offrendo servizi di staffing, formazione, outsourcing e talent management. Per azienda leader globale nelle soluzioni di mobilità ferroviaria...
-
Product Quality Assurance Specialist
2 settimane fa
Toscana, Italia Hitachi A tempo pienoAbout Us A career at Hitachi Rail will help create a legacy. With operations in every corner of the world our work goes to the cutting‑edge of digital transformation and technology. From the multicultural strength of our global organisation to the sustainable and innovative ways we work to bring people together there’s something for everyone to get stuck...
