Quality Specialist
2 settimane fa
Job Overview
This role is assigned to designated Delivery Unit(s), sponsor(s), business line(s) and/or specific tasks as defined by the line manager (LM). The purpose of this role is to carry out and adopt the global Quality Plan according to the specific needs defined by the scope of the assignment, to assist the assigned business line staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines. Contribute to the development and be responsible for the implementation of specific quality improvement initiatives as agreed with the relevant assigned business lines. Provide advice and support to relevant key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions.
Essential Functions
- Adopt and implement the global Quality Management Plan within the scope of the assignment with the support of a mentoring Quality Manager/Senior Quality Specialist, this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness.
- Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery. Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management Plan and Risk Management Program, monitor the implementation and delivery.
- Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.
- Work in close cooperation with teams to manage non-compliance, quality issues, assist in planning corrective/preventive actions, as applicable according to SOPs. ;
- Inform the assigned business line and Quality Assurance of quality issues according to SOPs.
- Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
- May provide assistance during audits and regulatory inspections to the operational teams to the extent agreed with Quality Management and as required by the applicable SOPs.
- Prepare periodic reports to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives.
- Upon agreement with the Line Manager: Perform any other reasonable tasks as required by the role.
**Qualifications**:
- 2 years’ experience in Clinical Monitoring in Italy
- Sound working knowledge of medical terminology, IQVIA Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), applicable regulatory requirements, quality management processes. Knowledge of National and International Regulations and Drug Development processes.
- Knowledge of Italian Pharmaceutical industry operations.
- Good organizational, interpersonal and communication skills.
- Good judgment and decision-making skills.
- Good influencing and negotiation skills.
- Excellent problem solving skills.
- Ability to travel within the region/country.
- Ability to lead and motivate a clinical team. Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.
- Fluent in Italian and English.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at
-
Internship Quality Specialist
2 settimane fa
Milano, Lombardia, Italia Pirelli A tempo pienoInternship Quality Specialist The candidate, assisted by the company tutor, will be involved in all the activities related to strategy definition, coordination and standardization at global level including: FMEA and CONTROL PLAN definition and management support Approval Process Management Capability studies and monitoring, traceability implementation ...
-
Quality Specialist
1 mese fa
Milano, Italia MP3 A tempo pienoThe Quality Specialist is the direct responsible for the quality control and equally he/she will be responsible for handling customer complaints by organizing, planning and managing work in this field. **Tasks and responsibilities**: - Contributes to implement and maintain the relevant management system, ensuring the compliance with the applicable...
-
Internship Quality Specialist
2 settimane fa
Milano, Italia Pirelli A tempo pienoInternship Quality Specialist The candidate, assisted by the company tutor, will be involved in all the activities related to strategy definition, coordination and standardization at global level including: • FMEA and CONTROL PLAN definition and management support • Approval Process Management • Capability studies and...
-
Tester/quality Assurance Specialist
7 giorni fa
Milano, Italia Business Competence srl A tempo pienoBusiness Competence nasce nel 2007 per offrire alle aziende soluzioni e servizi innovativi in ambito ICT & Business Strategy, dalla Security al Project Management. Adotta, sin dal primo giorno, un modello di sviluppo dal respiro internazionale basato non solo sulla solidità delle competenze tecnologiche, progettuali e gestionali, puntando sulla fiducia nei...
-
Quality Assurance Specialist
4 settimane fa
Milano, Italia Manpower A tempo pieno**Quality Assurance Specialist**: - Codice annuncio: 716051- - Data di pubblicazione: 17 aprile 2024- - Tipologia di assunzione: Assunzione Diretta- - Industria: biomedical-healthcare- - Validità annuncio fino a : 29 marzo 2025- - Posizioni ricercate : 1- - Da Remoto: No- - Full-time/Part-time: Full time - **:**Descrizione** ManpowerGroup ricerca per...
-
Global Marketing Quality Specialist
4 settimane fa
Milano, Italia Viatris A tempo pienoMylan Italia S.r.l. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of...
-
Process Quality Specialist
1 mese fa
Milano, Italia GSXecutive A tempo pienoImportante gruppo multinazionale in ambito automazione, che progetta e costruisce macchine ad alto contenuto tecnologico per diversi settori industriali a livello globale. **Competenze richieste** Il nostro Process Quality Specialist: - esegue attività di ispezione secondo le procedure del Sistema Qualità; - supporta il Plant Manager nella gestione, nel...
-
Quality Specialist
1 settimana fa
Milano, Italia Formula Spa A tempo pienoFormula è una società del Gruppo Impresoft costituito da un insieme di aziende specializzate e complementari che declina la propria offerta in **4 Competence Center: Business Solutions, Industry Solutions, Customer Engagement, Corporate Resilience**. Le sinergie generate da queste integrazioni, unitamente alla combinazione di talenti, competenze,...
-
Quality Assurance Specialist
4 settimane fa
Milano, Italia HRM srl A tempo pienoHRM oggi è un ecosistema innovativo, in cui Strategia, Tecnologia e Formazione sono collegate per sviluppare meccanismi virtuosi e di crescita. Siamo un HUB progettuale che promuove la valorizzazione dei nostri talenti su progetti unici e affiancati da fonti di apprendimento da cui attingere. **Perché i nostri colleghi ci scelgono**: In HRM sono sempre...
-
Quality Specialist, Supplier Quality
4 settimane fa
Milano, Italia Hitachi Energy A tempo pieno**At Hitachi Energy our purpose is advancing a sustainable energy future for all. We bring power to our homes, schools, hospitals and factories. Join us and work with fantastic people, while learning and developing yourself on projects that have a real impact to our communities and society. Bring your passion, bring your energy, and be part of a global team...
-
Quality Assurance Specialist
1 mese fa
Milano, Italia Olon A tempo pienoOlon S.p.A. è un'azienda italiana, leader mondiale nella produzione di principi attivi (API) per il mercato generico e nel CDMO (Contract Development and Manufacturing). Olon possiede 11 siti produttivi - 8 in Italia, 1 in Spagna, 1 negli USA e 1 in India e 3 filiali commerciali. Siamo alla ricerca di un **Quality Assurance Professional **da inserire...
-
Senior Quality Specialist
1 mese fa
Milano, Lombardia, Italia Abbott Laboratories A tempo pienoJob descriptionReporting to Manager QA , we are looking for a Sr Quality Assurance Specialist to join our team in Italy.Major AccountabilitiesCreate / update QMS documentation in accordance with correspondent regulations, ISO standards and FDA guidelines and Abbott Division procedures; Participate in projects' meetings and manage / review project...
-
Quality Assurance
4 settimane fa
Milano, Milano, Provincia di Milano, Italia ManpowerGroup A tempo pienoManpower professional, divisione Life Sciences, per cliente del settore Api, sta ricercando un profilo di: QUALITY ASSURANCE SPECIALIST Il QA risponde al Quality Unit Manager ed al QA Supervisor Il profilo si occuper di: - Rivedere ed approvare i batch record di produzione e bollettini analitici prima della revisione da parte del Qualified Person -...
-
Quality Assurance
22 ore fa
Milano, Italia ManpowerGroup A tempo pienoManpower professional, divisione Life Sciences, per cliente del settore Api, sta ricercando un profilo di: QUALITY ASSURANCE SPECIALIST Il QA risponde al Quality Unit Manager ed al QA Supervisor Il profilo si occuper di: - Rivedere ed approvare i batch record di produzione e bollettini analitici prima della revisione da parte del Qualified Person -...
-
Quality Assurance
2 giorni fa
Milano, Italia ManpowerGroup A tempo pienoManpower professional, divisione Life Sciences, per cliente del settore Api, sta ricercando un profilo di: QUALITY ASSURANCE SPECIALIST Il QA risponde al Quality Unit Manager ed al QA Supervisor Il profilo si occuper di: - Rivedere ed approvare i batch record di produzione e bollettini analitici prima della revisione da parte del Qualified Person -...
-
Quality Assurance
4 settimane fa
Milano, Italia ManpowerGroup A tempo pienoManpower professional, divisione Life Sciences, per cliente del settore Api, sta ricercando un profilo di: QUALITY ASSURANCE SPECIALIST Il QA risponde al Quality Unit Manager ed al QA Supervisor Il profilo si occuper di: - Rivedere ed approvare i batch record di produzione e bollettini analitici prima della revisione da parte del Qualified Person -...
-
Quality Assurance
1 mese fa
Milano, Italia ManpowerGroup A tempo pienoManpower professional, divisione Life Sciences, per cliente del settore Api, sta ricercando un profilo di: QUALITY ASSURANCE SPECIALIST Il QA risponde al Quality Unit Manager ed al QA Supervisor Il profilo si occuper di: - Rivedere ed approvare i batch record di produzione e bollettini analitici prima della revisione da parte del Qualified Person -...
-
Quality Assurance
4 settimane fa
Milano, Italia Manpower A tempo pieno**Quality Assurance - Pharma**: - Codice annuncio: 716982- - Data di pubblicazione: 22 marzo 2024- - Tipologia di assunzione: Assunzione Diretta- - Industria: chimico-farmaceutico- - Validità annuncio fino a : 31 dicembre 2024- - Posizioni ricercate : 1- - Da Remoto: No- - Full-time/Part-time: Full time - **:**Descrizione** Manpower professional, divisione...
-
Quality Control Specialist
1 mese fa
Milano, Italia Richemont A tempo pienoPer il nostro HQ di Milano siamo alla ricerca di un Quality Control Specialist Le principali responsabilità saranno le seguenti: Supporto al team del Controllo Qualità prodotto finito fornitori esterni. Verificare la conformità dei prodotti realizzati dai fornitori, segnalare le non conformità in base al Codice Qualità previsto dalla...
-
Quality Assurance
5 giorni fa
Milano, Italia Manpower A tempo pienoDescrizioneManpower professional, divisione Life Sciences, per cliente del settore Api, sta ricercando un profilo di:QUALITY ASSURANCE SPECIALISTIl QA risponde al Quality Unit Manager ed al QA Supervisor Il profilo si occuperà di:- Rivedere ed approvare i batch record di produzione e bollettini analitici prima della revisione da parte del Qualified Person-...