Good Pharmacovigilance Practices Auditor
4 giorni fa
CPL & TAYLOR by Synergos srl - Ricerca e Selezione Personale Qualificato is seeking a highly skilled Good Pharmacovigilance Practices Auditor to join our team.
About the Role:The successful candidate will be responsible for managing QAS projects for the delivery of QA GVP services to Clients, ensuring full compliance with the applicable GVP Legislation, Client's requirements, and the Regulatory Business Quality Standards.
Key Responsibilities:- Prepare and perform audits on behalf of clients, and relevant reporting to them.
- Assist clients in supporting their Annual Audit plan.
- Collaborate with the QA Director to manage the external Auditors and engage them as appropriate.
- Develop the workflow and operational planning for the QA GVP Services provided.
- Ensure that Quality & Projects Plans, are developed according to client requirements.
- Ensure oversight for day-to-day interactions with all staff involved in the services delivery.
- Develop standard operating procedures and work guidance and/or reviews Client's SOPs if applicable, to ensure full compliance.
- Contribute to GVP quality management plans and compliance program.
- Assist clients in audit/inspection readiness.
- Ensure tracking of compliance metrics.
- Assist clients in identifying and up-following up on corrective action plans arising from audits and inspections.
- Bachelor's degree in life science disciplines.
- At least 5 years of experience as a GVP QA Consultant and Auditor.
- English, Very good/Fluent.
- GVP regulations.
- Auditing (and related qualification if required).
CPL & TAYLOR by Synergos srl - Ricerca e Selezione Personale Qualificato is a leading international consultancy firm operating within the Life Sciences industry & Technology sector. We help organizations gain the best business value through technology-enabled solutions and achieve excellence in business operations.
We offer a dynamic and international work environment with opportunities for professional growth, flexible working arrangements to support work-life balance, and a competitive salary range.
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