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
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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