Gcp Quality Assurance Manager o di Un Gcp Quality

6 mesi fa


Milano, Italia Società Italiana di Medicina Farmaceutica A tempo pieno

LB Research (CRO con sede a Cantù) ricerca di un GCP Quality Assurance Manager o di un GCP Quality Assurance.

Possibilità di una posizione con contratto a tempo indeterminato e possibilità di svolgere parte del lavoro in Smart Working.

Profilo QA

Requisiti richiesti QA:

- Almeno 2/3 anni di esperienza nel ruolo
- Laurea magistrale
- Formazione in accordo al DM 15/11/2011

Mansioni da ricoprire:

- Revisione dei QMS Change Control Plans.
- Revisione/ approvazione delle SOPs e altri documenti del QMS. - Qualifica/ Riqualifica di Service Providers.
- Organizzazione trainings per lo Staff interno ed esterno.
- Revisione Quality Agreement con GxP Service Providers.
- Preparazione/ revisione dei documenti necessari per Audits.
- Valutazione non-conformità e valutazione adeguatezza CAPA Plans,
- Supervisione dell’implementazione dei CAPA Plans.
- Prendere parte al Risk Assessment Team.
- Quality control dei documenti studio specifici.
- Conduzione e reportistica di GCP computerized system Periodic Reviews.
- Supporto allo Staff in relazione a quality issues.
- Mantenimento dell’Archivio.

Profilo QAM

Requisiti richiesti QAM:

- Almeno 5 anni di esperienza nel ruolo
- Laurea magistrale
- Formazione in accordo al DM 15/11/2011
- Requisito plus: Auditor ISO 9001: 2015

Mansioni da ricoprire:

- Collegamento primario con la Direzione, Sponsor/Cliente e risorse interne ed esterne (personale LB e fornitori di servizi) per questioni di qualità.
- Revisione dei QMS Change Control Plans e supervision della relativa implementazione.
- Pianificazione della revision delle SOPs e Quality Manual.
- Revisione/ approvazione delle SOPs e altri documenti del QMS.
- Riaqualifica dello Staff interno e dei Service Providers.
- Pianificazione, verifica e reporting della formazione del personale.
- Preprazione/ revision del Quality Agreement con GxP Service Providers.
- Programmazione, pianificazione e coordinamento degli audits promossi da LB.
- Coordinamento delle attività di audits del QMS promossi dallo Sponsor/Cliente e delle ispezioni del QMS da parte delle Autorità Regolatorie.
- Mantenimento del registro delle non conformità, valutazione delle non conformità spontanee ricevute, valutazione dell'adeguatezza dei CAPA proposti, supervisione dell'attuazione dei CAPA concordati.
- Prendere parte al Risk Assessment Team.
- Prendere parte all’Emergency Management Team incaricato dell’attuazione del Business Continuity Plan.
- Quality control dei documenti studio specifici.
- Pianificazione, conduzione e reportistica di GCP computerized system Periodic Reviews.
- Supporto allo Staff in relazione a quality issues.

Richieste

Questo servizio è fornito gratuitamente da SIMeF a tutti.



  • Milano, Italia JSB SOLUTIONS S.R.L A tempo pieno

    **JSB Solutions**, società di servizi nel settore Life Science che offre consulenza, gestione di studi clinici e sviluppo software, con 3 sedi in Italia (Firenze, Parma e Milano) è alla ricerca di un **Quality Assurance GCP Consultant**_ (JSB.FRK.24.024)_ da inserire all'interno della nostra divisione **Quality Assurance**. - attività di implementazione e...


  • Milano, Italia Fondazione Telethon ETS A tempo pieno

    Fondazione Telethon is one of Italy's leading non-profit organisations. Our mission is to invest in the best scientific research to arrive at a cure for rare genetic diseases. For these diseases, precisely because of their rarity, there is often no research, no therapies, no cure. We want to change this state of affairs because every person is important to...


  • Milano, Lombardia, Italia Jefferson Wells A tempo pieno

    Job SummaryThe Global GCP Compliance Quality Assurance Manager will be responsible for ensuring compliance with Good Clinical Practices (GCP), quality procedural documents, legislation and applicable guidelines within the Clinical Research and Development function.The purpose of this role is to interact with all personnel at the Corporate Drug Development to...


  • Milano, Italia Jefferson Wells A tempo pieno

    The purpose of the role is to ensure compliance with the activities and processes of the Clinical Research and Development function to Good Clinical Practices (GCP), quality procedural documents, legislation and applicable guidelines.In addition, purpose of the role includes the interactions with all personnel at the Corporate Drug Development to provide...


  • Milano, Italia Jefferson Wells A tempo pieno

    Jefferson Wells is looking for a QC Clinical GCP Specialist on behalf of a pharmaceutical company based in Milano (Lombardia).The QA GCP Specialist ensures support so that the processes relating to Clinical Trials are conducted in accordance wlth current national and International leglslatlon, the relevant guldellnes and company's standard operating...


  • Milano, Lombardia, Italia Jefferson Wells A tempo pieno

    Job DescriptionThe purpose of this role at Jefferson Wells is to ensure compliance with the activities and processes of the Clinical Research and Development function to Good Clinical Practices (GCP), quality procedural documents, legislation and applicable guidelines.This role will interact with all personnel at the Corporate Drug Development to provide...


  • Milano, Lombardia, Italia Jefferson Wells A tempo pieno

    Quality Assurance in Clinical TrialsJefferson Wells is hiring a Quality Assurance Specialist to support a pharmaceutical company in Milano, Italy.The QA Specialist will ensure that clinical trials are conducted in accordance with current national and international legislation, guidelines, and company standard operating procedures.Key responsibilities...


  • Milano, Lombardia, Italia Jefferson Wells A tempo pieno

    **Job Title:** Clinical GCP Compliance Specialist**Location:** Milano (Lombardia)**About the Job:We are seeking a highly skilled Clinical GCP Compliance Specialist to join our team at Jefferson Wells. As a Clinical GCP Compliance Specialist, you will be responsible for ensuring that clinical trials are conducted in accordance with current national and...


  • Milano, Lombardia, Italia Jefferson Wells A tempo pieno

    The purpose of this role at Jefferson Wells is to ensure compliance with the activities and processes of the Clinical Research and Development function to Good Clinical Practices (GCP), quality procedural documents, legislation and applicable guidelines.Main Responsibilities:To ensure the implementation and management of the Clinical Research and Development...

  • Clinical QA Specialist

    4 settimane fa


    Milano, Lombardia, Italia Jefferson Wells A tempo pieno

    At Jefferson Wells, we are seeking a highly skilled QC Clinical GCP Specialist to join our team. This key role is responsible for ensuring that clinical trials are conducted in accordance with current national and international legislation, guidelines, and company standard operating procedures. The Quality Assurance Specialist will be responsible for the...


  • Milano, Italia Thermo Fisher Scientific A tempo pieno

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources...


  • Milano, Lombardia, Italia Adecco Filiale Di Milano Volta A tempo pieno

    Job DescriptionWe are seeking a highly skilled Quality Assurance Manager to join our team at Adecco Filiale Di Milano Volta. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our mission-critical projects.Key Responsibilities:Develop and implement quality programs and processes to ensure predictable...

  • Quality Assurance Manager

    3 settimane fa


    Milano, Lombardia, Italia Adecco Italia A tempo pieno

    Job Title: Quality Assurance ManagerJob Summary:As a Quality Assurance Manager at Adecco Italia, you will be responsible for ensuring the quality of mission-critical projects. Your role will involve implementing quality programs and 'Right First Time' practices for various disciplines, including CSA, electrical, mechanical, and control systems.You will also...


  • Milano, Lombardia, Italia Adecco Italia Spa A tempo pieno

    Job Summary: We are seeking a highly skilled Quality Assurance Manager to join our team at Adecco Italia Spa. As a Quality Assurance Manager, you will be responsible for ensuring the quality of our mission-critical projects, from mechanical completion to handover. You will lead the quality process, implement quality programs, and manage quality...

  • Quality Specialist

    5 mesi fa


    Milano, Italia Novasyte A tempo pieno

    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...

  • Senior Devops Gcp

    4 settimane fa


    Milano, Lombardia, Italia Herzum A tempo pieno

    Req. 18808 - Senior Devops GcpTipo Contratto: Indeterminato, Da definireP.IVA Per uno dei nostri Partner, stiamo cercando un Senior DevOps GCP per la nostra squadra di sviluppo.Descrizione del ruolo:Noi a Herzum siamo alla ricerca di un professionista esperto in DevOps GCP per la reingegnerizzazione delle nostre applicazioni in ottica microservizi.Competenze...


  • Milano, Lombardia, Italia Abbott Laboratories A tempo pieno

    Job Summary:As a Quality Assurance Manager at Abbott Laboratories, you will oversee all aspects of Quality Assurance at a site, ensuring a robust Quality System that meets regulatory standards.Key responsibilities include providing strategic direction and tactical assistance on quality systems and quality issues, ensuring compliance with local and global...

  • Quality Assurance Manager

    4 settimane fa


    Milano, Lombardia, Italia Link HR A tempo pieno

    Quality Assurance ManagerLink HR ricerca un Quality Assurance Manager da inserire all'interno dell'area Qualità per potenziamento di una storica azienda del territorio operante nel settore gomma plastica.Descrizione del ruolo:Gestire e coordinare il team di controllo qualità all'interno dello stabilimento;Sviluppare, implementare e monitorare politiche e...


  • Milano, Italia Dacomat Srl A tempo pieno

    Siamo alla ricerca di un esperto GCP con competenze in servizi, storage e DevOps da REMOTO!Stiamo cercando un profilo con una solida conoscenza dei servizi e dello storage di Google Cloud Platform, oltre a competenze nei linguaggi di programmazione e negli strumenti DevOps.Competenze richieste: Servizi e Storage GCP: Cloud Function Spanner BigQuery BigTable...


  • Milano, Lombardia, Italia Adecco Italia S.P.A. A tempo pieno

    Job Description:Adecco Italia S.P.A. is seeking a highly skilled Quality Assurance Manager to join our team. As a QA Manager, you will be responsible for ensuring the quality of our mission-critical projects, from mechanical completion to handover. Your extensive knowledge of CSA, electrical, mechanical, and control systems will be invaluable in this...