Computer System Validation (CSV) Specialist

Settore: / Engineering /
Azienda: Randstad Italia Spa
Data annuncio: 24/01/2022
Sede di lavoro: Frosinone

Randstad HR Solutions, for an important chemical pharmaceutical company, is loooking for a 


Computer System Validation (CVS) Specialist  

based in Ferentino (FR)



How will you make an impact?


Ensure that the computerized systems are validated and in compliance with the main Italian, European and American regulatory requirements (NBF/EU Annex/ CFR).




Ensure the execution of validation activities for CSV projects according to the timeline, procedures and the priorities defined by the company

Lead cross functional team and external personnel on assigned projects as defined within the Proactive Quality plan

Draft the main validation documents (URS, plans, risk analysis, test protocols and reports) in accordance with the internal procedures, collaborating with other departments and external consultants

Ensure that the validation documentation produced or issued by suppliers complies with internal quality standards.

Ensure the regular planning and implementation of CSV training.

Provide training for external personnel involved in validation activities.

Ensure the continuous update of CSV procedures according to the internal, industry and regulatory trend.

Support the management of external personnel involved in validation activities

Administrators Audit Trail Review

Computer System/SAP access periodic review

Management of any related non-conformity emerged during the Audit Trail/periodic review

Support on the resolution of any anomalies emerged Computer Systems

Support on the management of deviations involving Computer Systems.

Participation during customer and regulatory inspections

Support for Proactive Quality/Data Integrity initiatives




Degree pharma, chemical, engineering on computer science



Minimum 2 year computer system validation experience

Pharma/Manufacturing experience



Knowledge, Skills, Abilities

Knowledge of GMPs, Data Integrity, GAMPs and CFR part 11 regulations;

Strong interpersonal skills with proven ability to build and maintain relationships, teambuilding, adaptability, excellent problem solving & communication skills

Fluent in Italian and English


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