Gcp/Pv Auditor

hace 2 meses

Barcelona, España Healthcare Businesswomen’S Association A tiempo completo

.Job Description SummaryIn 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 identification and implementation of quality assurance training needs for Global GxP Audit and other business partners.The audits performed on behalf of Global GxP Audit include all audit types across GCP and PV disciplines including internal and external targets.How would you like to be a key part of the Global Auditing at Novartis, building upon and maintaining our exceptional standards? We pursue amazing talent across Spain This position comes with a flexible location and we are ready to hire this role in the city of preference (within Spain) of the successful candidate.Job DescriptionIn this role you will be required to travel up to 60% of time.Major accountabilities:Plan, lead, conduct, document, report and follow-up of GCP/PV audits according to the requirements specified in the respective Novartis procedures as well as applicable regulations, standards, quality agreements, and guidance documented.For this entry-level global auditor role, audits will typically be limited to low risk GCP/PV activities such as Investigator site audits, single service vendors, systems/process, Patient Oriented Programs, etc. Auditor may assist in supporting complex audits (Country Organizations, multiservice vendors, high risk vendors, etc).Provide technical guidance and training on audit activities.Ensure appropriate escalation to responsible management in case of critical audit findings and support immediate follow-up measures according to the Novartis requirements on Management Escalations and other relevant procedures. Ensure adequate definition and recording of mitigation plans when applicable.Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP).Maintain current knowledge of regulations, standards, and guidance documents.Minimum Requirements:Education: Degree in natural/biological sciences or equivalent (or an equivalent mix of education and experience).5 years GCP/GPvP/clinical/industry/health authority experience or equivalent (1-2 years of GCP/PV auditing experience is preferred).Thorough knowledge of applicable GCP, GPvP and GxP regulations, guidelines, policies and procedures.Ability to manage and objectively evaluate compliance issues.Ability to address a variety of tasks within the same timeframe while maintaining oversight; maintain a moderate degree of independence with respect to decision making and problem solving.Fluent English, at operational and functional level.Desirable requirements:Experience with Health Authority inspections and interaction

  • Gcp/Pv Auditor

    hace 2 meses

    Barcelona, España Novartis A tiempo completo

    .SummaryIn 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...

  • Gcp/pv Auditor

    hace 2 meses

    Barcelona, España Novartis A tiempo completo

    **Summary**: 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...

  • Gcp/Pv Auditor

    hace 2 meses

    Barcelona, España Healthcare Businesswomen’S Association A tiempo completo

    Job Description SummaryIn 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...

  • Gcp/Pv Auditor

    hace 2 meses

    Barcelona, España Healthcare Businesswomen’S Association A tiempo completo

    Job Description Summary 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...

  • Gcp/Pv Auditor

    hace 2 meses

    Barcelona, España Es06 (Fcrs = Es006) Novartis Farmacéutica, S.A. A tiempo completo

    In this role you will be required to travel up to 60% of time. Major accountabilities: Plan, lead, conduct, document, report and follow-up of GCP/PV audits according to the requirements specified in the respective Novartis procedures as well as applicable regulations, standards, quality agreements, and guidance documented.For this entry-level global auditor...

  • Gcp/Pv Auditor

    hace 1 mes

    Barcelona, Barcelona, España Es06 (Fcrs = Es006) Novartis Farmacéutica, S.A. A tiempo completo

    Job Summary: We are seeking a highly motivated and detail-oriented Gcp/Pv Auditor - Compliance Specialist to join our team at Novartis Farmacéutica, S.A. As a Gcp/Pv Auditor - Compliance Specialist, you will be responsible for planning, leading, conducting, documenting, reporting, and following up on GCP/PV audits according to Novartis procedures and...

  • GCP/PV Auditor

    hace 4 semanas

    Barcelona, España Novartis A tiempo completo

    SummaryIn 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(GPv P) and the current GCP/PV regulations. You will provide GCP/PV related quality guidance and assist...

  • GCP/PV Auditor

    hace 4 semanas

    Barcelona, España ES06 (FCRS = ES006) Novartis Farmacéutica, S.A. A tiempo completo

    In this role you will be required to travel up to 60% of time.Major accountabilities:Plan, lead, conduct, document, report and follow-up of GCP/PV audits according to the requirements specified in the respective Novartis procedures as well as applicable regulations, standards, quality agreements, and guidance documented.For this entry-level global auditor...

  • Global Quality Assurance Expert

    hace 3 semanas

    Barcelona, Barcelona, España Novartis A tiempo completo

    About the JobWe are seeking a highly skilled Global Quality Assurance Expert to join our team as a GCP/PV Auditor. In this role, you will lead and support independent audits, ensuring compliance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) regulations.

  • GCP/PV Compliance Specialist

    hace 7 días

    Barcelona, Barcelona, España Es06 (Fcrs = Es006) Novartis Farmacéutica, S.A. A tiempo completo

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    hace 6 meses

    Barcelona, España Novartis A tiempo completo

    **Summary**: Location: Spain/flexible (proximity to international airport is needed). 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...

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    hace 1 mes

    Barcelona, Barcelona, España Mygwork A tiempo completo

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    hace 3 semanas

    Barcelona, Barcelona, España Mygwork A tiempo completo

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    hace 3 semanas

    Barcelona, Barcelona, España Novartis A tiempo completo

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    hace 3 semanas

    Barcelona, Barcelona, España ES06 (FCRS = ES006) Novartis Farmacéutica, S.A. A tiempo completo

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    hace 1 semana

    Barcelona, España Novartis A tiempo completo

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    Barcelona, Barcelona, España Es06 (Fcrs = Es006) Novartis Farmacéutica, S.A. A tiempo completo

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    hace 2 meses

    Barcelona, España Innovative Medicines A tiempo completo

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    hace 3 semanas

    Barcelona, Barcelona, España ES06 (FCRS = ES006) Novartis Farmacéutica, S.A. A tiempo completo

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