IT Computer System Validation

1 giorno fa

Piombino Dese, Italia Stevanato Group A tempo pieno

We are looking for **IT Computer System Validation (CSV) Specialist** to be insert in our iDigital Office.

She/He will contribute to the employment of the GAMP methodologies with compliance to FDA regulations and ISO standards in the planning, implementation, and validation of GxP critical systems supported by our iDigital office and management of Change Management process during their lifecycle.

**Key Responsibilities**
- Writing validation protocols
- Performing test activities according GXP regulations

LI-DNI

**Qualifications**
- University Degree, preferably in Technical/Scientific related field
- Fluent in English
- +2 years of Computer System Validation experience in a regulated, manufacturing environment within the pharmaceutical or medical device industry have to be considered as a plus
- Direct experience within one of the following areas: Computer System Validation (CSV), Data Integrity, 21CFR Part 11, Enterprise Systems Qualification, Master Validation Plans, Standard Operating Procedure (SOP), Change Control, Data Analysis, Deviations, Risk Assessments, CAPAs, GMP investigations, Quality Risk Management (QRM)

Adherence to **Stevanato Group’s Values**: Trust and respect everyone; Be accountable; Be ethical, always; Listen and communicate with transparency and honesty; Deliver results.

**About Us**

We are a dynamic organization with great customers and a culture where people are valued and empowered to deliver amazing results. We are also growing and looking to hire talented and passionate individuals to join our team

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