Gvp Auditor & Consultant Lazio

Gvp Auditor & Consultant
Roma
Lazio, Lazio

Job InformationIndustry: Pharma Job Type: Full time Work Experience: 4-5 years Date Opened: 29/02/2024 City: Roma Province: Lazio Country: Italy Postal Code: 00141 Other City: Verona Hybrid Job: Yes About UsWe are experts in the Life Sciences industry & Technology.

We are a long-standing partner for technology and expert service provider across Clinical, Regulatory, Quality, Pharmacovigilance and Medical Affairs domains.

We help companies to gain the best business value through technology-enabled solutions and achieve excellence in business operations.

Job DescriptionPURPOSE: Manages QAS projects for the delivery of QA GVP services to Clients, in full compliance with the applicable GVP Legislation, Client's requirements and the Regulatory Business Quality Standards.

RequirementsACCOUNTABILITIES: Prepares and performs audits on behalf of clients, and relevant reporting to themAssist clients in supporting their Annual Audit planCollaborate with the QA Director to manage the external Auditors and engage them as appropriateDevelops the workflow and operational planning for the QA GVP Services providedEnsures that Quality & Projects Plans are developed according to client requirementsEnsures oversight for day-to-day interactions with all staff involved in the services deliveryDevelops standard operating procedures and work guidance and/or reviews Client's SOPs if applicable, to ensure full complianceContributes to GVP quality management plans and compliance programAssists clients in audit/inspection readinessEnsures tracking of compliance metricsAssists clients in identifying and following up on corrective action plans arising from audits and inspectionsPROFESSIONAL BACKGROUND & EXPERIENCE: Bachelor's degree in life science disciplinesAt least 5 years of experience as a GVP QA Consultant and AuditorEnglish, Very good/FluentGVP regulationsAuditing (and related qualification if required)

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