Gvp Auditor

**Job Information**:
Industry

**Pharma***

Work Experience

**4-5 years***

City

**Roma***

Province

**Lazio***

Country

**Italy***

Postal Code

**00141***

Other City

**Verona***

Hybrid Job

**Yes***

**About us**:
We are Business and Technology experts in the Life Sciences industry.

We are a long-standing Partner and Service Provider across Clinical Development, Regulatory and Compliance, Quality Management, Pharmacovigilance, and Medical Affairs domains.

We help pharmaceutical, biotechnology, nutraceutical, medical device, universities, hospitals and non-profit organisations to gain the best business value through technology-enabled solutions and achieve excellence in business operations.
- 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
- Assist clients in supporting their Annual Audit plan
- Collaborate 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 up following up on corrective action plans arising from audits and inspections
- PROFESSIONAL BAKGROUND & 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)