Gcp Auditor with Data Management Background

hace 4 días

Madrid, España Adamas Consulting A tiempo completo

Company Description

**Job Description**:
**Responsibilities**:

- Perform GCP quality assurance projects which fall within the job holder’s areas of expertise on behalf of client companies within the pharmaceutical industry
- Contribute to upskilling of consultants in the conduct of vendor and systems audits
- Actively participate in the ADAMAS Learning Management System
- Assist with business development activities
- Perform other reasonable duties as requested by the job holder’s Line Manager
- Leading, planning, conducting, documenting and following-up of global GCP audits according to applicable regulations, standards, quality agreements, and guidance documents
- Maintaining current knowledge of regulations, standards, guidance documents, industry initiatives and trend that impact GCP

**Qualifications**:
**Requirements**:

- BSc in Life Science Preferred
- Experience in conducting and leading internal and external GCP audits for a variety of stakeholders
- Experience in conducting a range of service provider audits (e.g., full service CRO, biostatistics, data management, phase I)
- Experience in conducting GCP systems audits
- Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site
- Experience in conducting GCP mock inspections to Competent Authority standard considered a significant advantage
- Expert knowledge of national and international GCP legislation and guidelines
- Proficient in managing projects and ensuring deliverables are provided on time
- Ability to identify issues and offer solutions in a pragmatic way
- Ability to travel up to 40% travel and the ability to conduct remote audits

Additional Information

Our people and the way we work set us apart. We work closely with our clients, providing industry-leading innovation and knowledge to deliver solutions that add genuine value to their business.

We place great worth on development and collaboration so we can best succeed together. When needed we also place great importance on intellectual curiosity and the ability to work autonomously.

  • Gcp/Pv Auditor

    hace 2 meses

    Madrid, España Advanced Accelerator Applications (Italy) - S... A tiempo completo

    .In this role you will lead, support and report independent GCP/PV audits and approve follow-up corrective and preventive activities according to the Novartis Quality Systems and Standards, Good Clinical Practice (GCP)/Good Pharmacovigilance Practice (GPvP) and the current GCP/PV regulations. You will provide GCP/PV related quality guidance and assist in the...

  • Gcp Auditor

    hace 4 días

    Madrid, España Adamas Consulting A tiempo completo

    Company Description **Job Description**: **Responsibilities**: - Perform GCP quality assurance projects which fall within the job holder’s areas of expertise on behalf of client companies within the pharmaceutical industry - Contribute to upskilling of consultants in the conduct of vendor and systems audits - Actively participate in the ADAMAS Learning...

  • Sr. Gcp Auditor

    hace 5 horas

    Madrid, España Novartis A tiempo completo

    Global Senior GCP/PV Auditor How would you like to be a key part of the Global Auditing at Novartis, building upon and maintaining our exceptional standards? As Global Senior GCP/PV Auditor, you will be responsible for leading, supporting and reporting independent GCP and PV audits and approving follow-up CAPAs according to Novartis guidelines and GCP...

  • Global Gcp/pv Auditor

    hace 6 días

    Madrid, España Novartis A tiempo completo

    766! 766 million patients reached in 2021, Billion treatments supplied, 21 major approvals in US, EU, Japan and China and 3 breakthrough therapy designations by FDA only in 2021. Would you also like to be a key part of the Global Auditing at Novartis, building upon and maintaining our exceptional standards? We are looking for outstanding professionals with...

  • Gcp Consultant

    hace 7 meses

    Madrid, España Adamas Consulting A tiempo completo

    Company Description ADAMAS is a well-established, leading provider of mission-critical regulatory compliance and consulting services to the global pharmaceutical industry. It operates across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Computer Systems Compliance...

  • Gcp Data Engineer

    hace 2 meses

    Madrid, España Adroit People Ltd. A tiempo completo

    **1. Design, implement, and manage data pipelines on Google Cloud using Apache Nifi, Dataproc, BigQuery, Dataflow, and other GCP services.** **2. Develop Spark and Hadoop workflows to process large datasets in Dataproc, ensuring data reliability and efficiency.** **3. Integrate Dataproc workflows with other GCP data services like Cloud Storage, BigQuery,...

  • Data Engineer-gcp

    hace 2 meses

    Madrid, España Adroit People Ltd. A tiempo completo

    **Spanish native with english secondary**: - **Hybrid mode of working (Remote + Office both)**: - **8*5, Some roles are on call mode of working (24 Hrs support kind of role)**: - **Experience working with Telcom will be preferred** 1. Design, implement, and manage data pipelines on Google Cloud using Apache Nifi, Dataproc, BigQuery, Dataflow, and other...

  • Auditor de Calidad Gcp en Desarrollo Clínico

    hace 3 semanas

    Madrid, Madrid, España Saint Felix De Lunel A tiempo completo

    MisiónComo Auditor de Calidad Gcp en Desarrollo Clínico, te invitamos a unirse a nuestro equipo de profesionales comprometidos con la calidad y la excelencia en ensayos clínicos.

  • Gcp Cloud Lead Security

    hace 1 semana

    Madrid, España Itjobs A tiempo completo

    .SEEKING : GCP Cloud Lead SecurityWe are looking for a GCP Cloud Lead Security.The GCP Cloud Lead Security will be responsible for defining low-level strategy and configurations and supporting the deployment of security solutions as part of GCP Cloud Strategy (Data Migration, Endpoint protection including server protection, Cloud App Security, Identity...

  • Gcp Cloud Lead Security

    hace 2 días

    Madrid, España Itjobs A tiempo completo

    .SEEKING : GCP Cloud Lead Security We are looking for a GCP Cloud Lead Security.The GCP Cloud Lead Security will be responsible for defining low-level strategy and configurations and supporting the deployment of security solutions as part of GCP Cloud Strategy (Data Migration, Endpoint protection including server protection, Cloud App Security, Identity...

  • Data Engineer On Gcp

    hace 2 meses

    Madrid, España Adroit People Ltd. A tiempo completo

    **Location: Madrid, Spain** **Permanent: Hire** **4+ years Experienced** **Data Engineer on GCP** 1. Design, implement, and manage data pipelines on Google Cloud using Apache Nifi, Dataproc, BigQuery, Dataflow, and other GCP services. 2. Develop Spark and Hadoop workflows to process large datasets in Dataproc, ensuring data reliability and efficiency. 3....

  • Gcp Data Architect

    hace 2 meses

    Madrid, España Devoteam Spain A tiempo completo

    Descripción de la empresaDevoteam es una consultora líder en Europa centrada en estrategia digital, plataformas tecnológicas, ciberseguridad y transformación empresarial a través de la tecnología.La tecnología está en nuestro ADN y creemos en ella como una palanca capaz de impulsar el cambio a mejor, manteniendo un equilibrio que nos permite ofrecer...

  • GCP Data Architect

    hace 2 meses

    Madrid, España Devoteam Spain A tiempo completo

    Descripción de la empresaDevoteam es una consultora líder en Europa centrada en estrategia digital, plataformas tecnológicas, ciberseguridad y transformación empresarial a través de la tecnología.La tecnología está en nuestro ADN y creemos en ella como una palanca capaz de impulsar el cambio a mejor, manteniendo un equilibrio que nos permite ofrecer...

  • Data Engineer on GCP

    hace 3 días

    Madrid, España LanceSoft Europe A tiempo completo

    Role: Data Engineer on GCP Location: Madrid, Spain Permanent: Hire 4+ years Experienced 1. Design, implement, and manage data pipelines on Google Cloud using Apache Nifi, Dataproc, BigQuery, Dataflow, and other GCP services. 2. Develop Spark and Hadoop workflows to process large datasets in Dataproc, ensuring data reliability and efficiency. 3. Integrate...

  • Data Engineer On Gcp

    hace 4 días

    Madrid, España Lancesoft Europe A tiempo completo

    Role: Data Engineer on GCP Location: Madrid, Spain Permanent: Hire 4+ years Experienced 1.Design, implement, and manage data pipelines on Google Cloud using Apache Nifi, Dataproc, BigQuery, Dataflow, and other GCP services.2.Develop Spark and Hadoop workflows to process large datasets in Dataproc, ensuring data reliability and efficiency.3.Integrate Dataproc...

  • Gcp Data Architect

    hace 2 meses

    Madrid, España Devoteam A tiempo completo

    Devoteam es una consultora líder en Europa centrada en estrategia digital, plataformas tecnológicas, ciberseguridad y transformación empresarial a través de la tecnología. La tecnología está en nuestro ADN y creemos en ella como una palanca capaz de impulsar el cambio a mejor, manteniendo un equilibrio que nos permite ofrecer a nuestra cartera de...

  • Gcp Data Architect

    hace 2 meses

    Madrid, España Devoteam Spain A tiempo completo

    **Descripción de la empresa** Devoteam es una consultora líder en Europa centrada en estrategia digital, plataformas tecnológicas, ciberseguridad y transformación empresarial a través de la tecnología. La tecnología está en nuestro ADN y creemos en ella como una palanca capaz de impulsar el cambio a mejor, manteniendo un equilibrio que nos permite...

  • Global Auditor – Clinical Practice Or Pharmacovigilance Auditor

    hace 2 semanas

    Madrid, España Novartis Farmacéutica A tiempo completo

    .Global Auditor – Clinical Practice or Pharmacovigilance Auditor Job ID REQ-10024686SpainSummary In this role you will lead, support and report independent GCP/PV audits and approve follow-up corrective and preventive activities according to the Novartis Quality Systems and Standards, Good Clinical Practice (GCP)/Good Pharmacovigilance Practice (GPvP) and...

  • Data Engineer on GCP

    hace 6 días

    Madrid, España LanceSoft Europe A tiempo completo

    Role: Data Engineer on GCPLocation: Madrid, SpainPermanent: Hire4+ years Experienced1. Design, implement, and manage data pipelines on Google Cloud using Apache Nifi, Dataproc, BigQuery, Dataflow, and other GCP services.2. Develop Spark and Hadoop workflows to process large datasets in Dataproc, ensuring data reliability and efficiency.3. Integrate Dataproc...

  • Data Engineer on GCP

    hace 5 días

    Madrid, España LanceSoft Europe A tiempo completo

    Role: Data Engineer on GCPLocation: Madrid, SpainPermanent: Hire4+ years Experienced1. Design, implement, and manage data pipelines on Google Cloud using Apache Nifi, Dataproc, BigQuery, Dataflow, and other GCP services.2. Develop Spark and Hadoop workflows to process large datasets in Dataproc, ensuring data reliability and efficiency.3. Integrate Dataproc...