Computer System Validation (Profilo Junior) Milano

Computer System Validation (Profilo Junior)
Milano
Lombardia, Milano

Job purpose**:

As Junior Computer System Validation (CSV) Specialist consultant supports clients in the entire Validation process with the purpose to guarantee the compliance of client quality processes to applicable regulations, implementing policies and procedures.

He has knowledge of FDA and European compliance regulations and the ability to evaluate Computer Systems from a compliance perspective and ensures adherence to the applicable standards (i. e. 21CFR Part 11, EU Annex 11).

He is involved in the authoring/updating of documentation related to computerized systems.

**Activities, Duties, Tasks and Responsibilities**:

He supports clients to:

- perform computerized system validation activities (issue of validation document: validation plan, protocols, test scripts, reports and more other)

- implement quality assurance practices and procedures

- manage ITS quality tasks (change control, deviations, CAPA, )

- investigate and troubleshoot problems linked to computerized systems

- identify compliance issues that require follow-up or investigation

- edit and update of documentation

**Professional Experience**:

- N/A no previous relevant professional experience in Computer System Validation.

**Professional knowledge**:

- Good knowledge of English language (written and spoken)

- Good knowledge of Office suite (Word, Excel, Power Point, )

- Ability to adhere to all policies, rules and regulations

**Professional Skills**:

- Customer management, communication and presentation skills

- Management of multiple projects with multiple stakeholders

- Problem Solving and Targeting goals

- Communicate effectively -orally, by phone, in person and writing

Contratto di lavoro: Tempo indeterminato

Stipendio: €1. 250, 00 - €1. 500, 00 al mese

Orario:

- Dal lunedì al venerdì

- No weekend

- Turno diurno