Computer Systems Validation Manager Milano

Computer Systems Validation Manager
Milano
Lombardia, Milano

Company Description

**Why are we here?

You may not know our name but we can guarantee you know our work - all we do has a positive impact on life, health and the environment.

Eurofins is by your side every day, from the food you eat to the medicines you rely on.

We work with the biggest companies in the world, making sure the products they supply are safe, their ingredients are authentic and labelling is accurate.

As a fast paced growing environment we are looking for natural born leaders that inspire passion in unique individuals and are not afraid to take risks in order to achieve goals.

Life at Eurofins is a meritocracy, where people are empowered to make decisions and are rewarded for their success.

We encourage independent thinkers who challenge the status quo and never accept the market's or the company's "usual way of doing things".

**Eurofins Scientific** is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries.

The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services.

It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies.

In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.

Group's key figures are approx.

5. 4 billion Euros turnover, over 900 laboratories across 50 countries and about 55, 000 staff.

**Job Description**:

**OVERALL OBJECTIVES**:

**ROLES & RESPONSIBILITIES**:

3.

Sound knowledge of Regulatory and cGMP guidelines along with Eudralex Annex 11 and 15 specifications.

4.

Advise and support those responsible for processes and systems in all CSV-related issues.

5.

Present validation documents during each phase of the validation cycle to all key stakeholders to obtain necessary approvals.

6.

Hands-on ability to perform ERES assessment.

7.

Document qualification protocols, gap, impact and risk assessments, requirements traceability matrix, URS, VP, VSR amongst others.

8.

Participate in any audits as required and address audit findings.

9.

From an operational perspective complete incident, change and problem management formalities, check validated systems regularly after implementation and provide on-going support for system changes.

Document and maintain SOPs for central IT systems.

10.

Learn and develop functional knowledge of all Eurofins IT systems as required.

**Qualifications**:

**_

Initial Educational Background:_

- Degree in Computer Science or equivalent Technical-Scientific Degree (Chemistry, Engineering)

**_ Type and duration of previous experience:_

- Minimum 5 years of Computer Systems Validation experience.

Experienced in a multi sites and multi countries environment.

**_

Mandatory skills:_

- Prior experience of software validating in a GxP environment.

- Sound knowledge of Data Integrity requirements.

- Willing to work during non-Business hours to meet validation cycle deadlines.

**_

Desirable experience:_

**_

Desirable Personal Qualities:_

- Multilingual abilities to work across our European Laboratories.

- Good communication skills (oral and written)

- Excellent interpersonal and organizational skills.

- Ability to work in a complex international environment.

- Eager to learn and continuously develop personal and technical capabilities.

Additional Information

- A launch pad into various management opportunities - within the many business lines of Eurofins globally - or into the management hierarchy in our different corporate functions.

- The opportunity to grow your skills in a demanding, fast growing organization.

- A chance to become part of a highly motivated international team of professionals.