Gcp/Pv Auditor
hace 2 meses
.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 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.About the Role 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 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. The 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.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.Experience with Health Authority inspections and interaction a plus
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Global Gcp/pv Auditor
hace 5 días
Madrid, España Novartis A tiempo completo766! 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...
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Global Gcp/pv Senior Auditor
hace 7 meses
Madrid, España Sandoz Farmacéutica, S.A. A tiempo completoSandoz is going through an exciting and trasformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture...
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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...
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Madrid, España Novartis Farmacéutica A tiempo completoGlobal Auditor – Clinical Practice or Pharmacovigilance Auditor Job ID: REQ-10024686Location: Spain 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...
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Madrid, España Novartis Farmacéutica A tiempo completoGlobal Auditor – Clinical Practice or Pharmacovigilance AuditorJob ID: REQ-10024686Location: SpainSummary: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...
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Auditor de Calidad Gcp en Desarrollo Clínico
hace 3 semanas
Madrid, Madrid, España Saint Felix De Lunel A tiempo completoMisiónComo 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.
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Gcp Auditor
hace 3 días
Madrid, España Adamas Consulting A tiempo completoCompany 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...
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Gcp Consultant
hace 7 meses
Madrid, España Adamas Consulting A tiempo completoCompany 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...
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Gvp Consultant
hace 5 días
Madrid, España Adamas Consulting A tiempo completoCompany Description **Job Description**: **Responsibilities**: - Planning, preparation, conduct, reporting, and follow up (including CAPA plans) of various types of Pharmacovigilance (PV) audits according to expected quality and timelines - Delivery of consultancy services (e.g., providing advice to clients and developing Standard Operating Procedures...
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Global Quality Assurance Specialist
hace 4 semanas
Madrid, Madrid, España Advanced Accelerator Applications (Italy) - S... A tiempo completoAbout the RoleIn this position, you will be a key part of the Global Auditing team at Advanced Accelerator Applications (Italy) - Spain, building upon and maintaining our exceptional standards. This role comes with a flexible location and we are ready to hire the successful candidate in the city of preference within Spain.Key ResponsibilitiesPlan, lead,...
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Quality Assurance Auditor
hace 5 días
Madrid, España PSI CRO A tiempo completoCompany Description We’re over 2,000 strong across the globe. We’re scientists, strategists, creatives, and innovators. We value individual brilliance and build a strong foundation for teamwork across all areas of our business. We love the challenge of our industry. We’re changing lives and redefining success every step of the way. You are dynamic....
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Quality Assurance Auditor
hace 5 días
Madrid, España PSI CRO A tiempo completoCompany Description We’re over 2,000 strong across the globe. We’re scientists, strategists, creatives, and innovators. We value individual brilliance and build a strong foundation for teamwork across all areas of our business. We love the challenge of our industry. We’re changing lives and redefining success every step of the way. You are dynamic....
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Gvp Consultant
hace 7 meses
Madrid, España Adamas Consulting A tiempo completoCompany 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...
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Gcp Auditor with Data Management Background
hace 3 días
Madrid, España Adamas Consulting A tiempo completoCompany 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...
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Sr. Manager, Auditor
hace 7 meses
Madrid, España Pfizer A tiempo completoWhy Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through...
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Quality Officer
hace 3 meses
Madrid, España Qualifyze A tiempo completo.About QualifyzeFounded in 2019, Qualifyze is a leading company in supply chain compliance management in the Life Sciences industry, trusted by over 1,200 pharmaceutical and healthcare companies globally. Our digital suite of solutions connects manufacturers, suppliers, and a global network of more than 250 auditors and quality experts. With a track record...
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Clinical QA Auditor
hace 4 días
Madrid, España Abbvie A tiempo completo**About AbbVie** - Home or Office-based in AbbVie locations across Europe - International travel - Comprehensive benefits package, with excellent progression opportunities **Role Objective**: The Clinical QA Auditor will be responsible to conduct the Clinical audit program, including scheduling, planning, reporting and resolution of Clinical audits across...
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Senior Compliance Specialist
hace 2 semanas
Madrid, Madrid, España Novartis Farmacéutica A tiempo completoJob SummaryIn this pivotal role, you will lead and support independent GCP/PV audits, ensuring compliance with Novartis Quality Systems and Standards, Good Clinical Practice (GCP)/Good Pharmacovigilance Practice (GPvP), and current regulations. Your expertise will provide quality guidance and assist in identifying training needs for Global GxP Audit...
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Clinical Qa Auditor
hace 4 semanas
Madrid, España Cmed Group Ltd A tiempo completo.The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India.The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I - IV) and...
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Pv Physician
hace 5 días
Madrid, España EastHORN Clinical Services A tiempo completo**Job summary**: We are looking for an experienced PV Physician with at least 3 years’ experience working as a Safety Physician in Clinical Trials within a CRO or Pharmaceutical company. The position involves working on assigned clinical trial projects and interacting with study physicians, clients, external Pharmacovigilance consultants, clinical...