Clinical Quality Assurance Specialist
4 giorni fa
Clinical Quality Assurance Specialist (GCP)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.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:We invite interested candidates to submit their applications expressly authorizing the processing of personal data in accordance with Legislative Decree ********.Our recruitment adheres to the provisions of Legislative Decree ********, and we welcome applications from candidates of any gender orientation or expression, sexual orientation, age, ethnicity, or religious belief.#J-*****-Ljbffr
-
Gmp Quality Assurance Specialist
1 settimana fa
Montà, Italia Philogen S.P.A. A tempo pienoGMP 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 responsible for: writing, reviewing and approving...
-
Gmp Quality Assurance Specialist
2 settimane fa
Montà, Italia Philogen A tempo pienoJob Title: GMP QUALITY ASSURANCE SPECIALISTDepartment: QAPhilogen 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 responsible for:writing, reviewing...
-
Quality Assurance Specialist
1 giorno fa
Montà, Italia Farmabios A tempo pienoFarmabios, società appartenente al Gruppo Axplora, azienda leader nella produzione di principi attivi, è alla ricerca di un/una Quality Assurance Specialist. A diretto riporto del Quality Assurance Manager, la risorsa dovrà possedere i seguenti requisiti Mansioni Audit clienti: programmazione, gestione e proposta CAPA plan Audit fornitori di materie prime...
-
Quality Assurance Specialist
2 settimane fa
Montà, Italia Bicego Hr Srl A tempo pienoQUALITY ASSURANCE SPECIALIST - Settore gioielleria Per una prestigiosa realtà internazionale del settore gioielleria e lusso , stiamo ricercando una figura di Quality Assurance Specialist da inserire nel team dedicato al controllo qualità e alla pianificazione delle attività con i fornitori. La risorsa, in supporto alla Responsabile Qualità, avrà un...
-
Quality Assurance Specialist
1 settimana fa
Montà, Italia Hays A tempo pienoValvole – Oil & Gas – Energy – Petrolchimico Quality Assurance Specialist – Provincia di VareseIl nostro cliente è una solida realtà industriale italiana con sede in provincia di Varese, parte di un importante gruppo nazionale e attiva da oltre 70 anni nel settore delle valvole. Con più di 150 collaboratori e una forte presenza internazionale,...
-
Quality Assurance Technician
2 giorni fa
Montà, Italia Burberry A tempo pienoSelect how often (in days) to receive an alert: Quality Assurance Technician Department: SC CENTRAL OPERATIONS Location: IT INTRODUCTION JOB PURPOSE To work at vendors and factories to make sure that products being produced meet the highest possible quality standard. The role is based in Piacenza, but with frequent travelling to vendors in Marche and Umbria...
-
Quality Assurance Manager
7 giorni fa
Montà, Italia G2 Recruitment A tempo pienoThe QA Manager will lead and implement quality assurance processes for a major infrastructure projects covering both road and railway construction. This role ensures compliance with Italian and EU standards, contractual requirements, and project specifications. Key Responsibilities Develop and maintain the project Quality Assurance Plan in line with ISO...
-
Quality Assurance Senior Verona
1 settimana fa
Montà, Italia Newchem Spa A tempo pienoNewchem azienda chimico farmaceutica produtttrice di API presente sul territorio per potenziamento dell'organico Quality Assurance del sito di Verona seleziona QUALITY ASSURANCE SENIOR ricerchiamo candidato/a che abbia · Ottima conoscenza ed applicazione delle Norme di Buona Fabbricazione (GMP); · Capacità nella gestione delle deviazioni dalle NBF e delle...
-
Quality Assurance Senior Verona
2 settimane fa
Montà, Italia Newchem Spa A tempo pienoNewchem azienda chimico farmaceutica produtttrice di API presente sul territorio per potenziamento dell'organico Quality Assurance del sito di Verona seleziona QUALITY ASSURANCE SENIOR ricerchiamo candidato/a che abbia · Ottima conoscenza ed applicazione delle Norme di Buona Fabbricazione (GMP); · Capacità nella gestione delle deviazioni dalle NBF e delle...
-
Artificial Intelligence Engineer
1 settimana fa
Montà, Italia Concept Quality Reply A tempo pienoStiamo cercando un/una Generative AI Quality Assurance Specialist! Siamo Concept Quality , la società del gruppo Reply specializzata in Quality Assurance e servizi di testing avanzato. Se sei appassionato/a di Intelligenza Artificiale Generativa e desideri contribuire a garantire che i modelli di IA producano risultati accurati, coerenti ed etici , potresti...
