Gvp Auditor & Consultant Lazio

Gvp Auditor & Consultant
Roma
Lazio, Lazio

We 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 Description PURPOSE:

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.

Requirements ACCOUNTABILITIES:

Prepares and performs audits on behalf of clients, and relevant reporting to them.

Assists clients in supporting their Annual Audit plan.

Collaborates with the QA Director to manage the external Auditors and engage them as appropriate.

Develops the workflow and operational planning for the QA GVP Services provided.

Ensures that Quality & Projects Plans are developed according to client requirements.

Ensures oversight for day-to-day interactions with all staff involved in the services delivery.

Develops standard operating procedures and work guidance and/or reviews Client's SOPs if applicable, to ensure full compliance.

Contributes to GVP quality management plans and compliance program.

Assists clients in audit/inspection readiness.

Ensures tracking of compliance metrics.

Assists clients in identifying and following up on corrective action plans arising from audits and inspections.

PROFESSIONAL BACKGROUND & EXPERIENCE:

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).

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