Gvp Auditor & Consultant Lazio

Gvp Auditor & Consultant
Roma
Lazio, Lazio

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)