Computer System Validation Csv Specialist Lazio

Computer System Validation Csv Specialist
Roma
Lazio, Lazio

dettagli offerta ferentino, lazio indeterminato categoria information technology sottocategoria developer riferimento CX226856 Location|Division Specific Information The pharmaceutical manufacturing plant in Ferentino 80km from Rome, with more than 850 employees, is specialized in commercial contract manufacturing of injectable drugs, both liquid and lyophilized formulations, with an increasing focus on biologics responsabilità HoH What will you do

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 Confidenziale of CSV procedures according to the internal, industry andregulatory 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 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 customer and regulatory inspections Support for Proactive Quality|Data Integrity initiatives esperienza 3 anni competenze How will you get here

Education Degree pharma, chemical, engineering on computer science Experience 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, exent problem solving & communication skills Fluent in Italian and English La ricerca è rivolta ai L. 903|77.

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livello di studio Laurea di primo livello 3 anni