It Auditor (Gxp) - Emea Milano

It Auditor (Gxp) - Emea
Milano
Lombardia, Milano

The role

As an IT Auditor (GxP) for the EMEA region, you will join a newly restructured and growing technology audit team within our global CRO client.

You will perform a variety of audit activities such as: vendor audits/vendor surveillance activities, internal computerized system audits, and contracted audits.

You will typically be the primary contact for any local computer systems related audit activities that are required to be performed.

The position is available on a hybrid or remote basis with a preference for being based in Ireland, the UK or rest of region Europe.

You will also:

- Participate in the review/approval of Computer System Validation deliverables.

provide consultation, mentoring and request adherence to compliance on GxP areas and FDA (21 CFR Part 11) requirements by ensuring quality activities are performed and documented in compliance with applicable regulations.

- Provide consultation and compliance advice (thanks to your knowledge of GxPs and your understanding of regulatory expectation) for the organization and support a quality framework that protects patient safety, data integrity and data privacy.

This includes interpretation of regulations and guidelines, searches of published information and interactions with other QA and regulatory professionals.

- Bring your expertise in international regulations and guidelines to support compliance projects such as management of quality issues, CAPA projects, or other Quality Assurance and cross-functional initiatives

- Experience in a Quality Assurance function

- Vendor technology audit experience

- Internal technology audit experience

- Experience in GCP or GxP areas, 21 CFR Part 11, Annex 11

- Computer Systems Validation (CSV) experience

- CRO experience preferable (either working for, or with)

The company offer a competitive salary and benefits package that includes a comprehensive health plan, company car allowance (country dependant), retirement plans, highly competitive pay, corporate bonus plan, time away from work, and other incentives along with a culture that promotes and priorities career development opportunities for each employee.

**Salary**: €58, 000. 00 - €93, 000. 00 per year