For our important client (pharmaceutical sector) we are looking for a
CSV - Computer System Validation Specialist
You will 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
Technical and soft Skills
• Degree pharma, chemical, engineering on computer science
• Minimum 3 year computer system validation experience
• Pharma/Manufacturing experience
• 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
Data inizio prevista: 01/07/2022
Categoria Professionale: Ingegneria Impiantistica
Settore: INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA
Città: Ferentino (Frosinone)
- Parlato: Ottimo
- Scritto: Ottimo
- Comprensione: Ottimo
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