CSV Consultant

Job description

Fortil is an international engineering and technology consulting group built on an independent model, bringing together over 2,500 employees. With 30 offices across 14 countries, Fortil fosters entrepreneurial freedom and the empowerment of individual potential. We are looking for a CSV Consultant for a strategic project. Location: Aprilia. Responsibilities: Validation of computerized systems in the Life Science sector (e.g. laboratory instrumentation control systems, automation systems and quality systems - ERP, LIMS, DMS - according to the GxP reference regulations and GAMP Guidelines; Support in the management of remediation or requalification projects for the adaptation of computerized systems to the FDA 21 CFR part 11/EU Annex 11 regulations and to the Data Integrity regulations and guidelines; Periodic review of computerized systems and user audit trails; Drafting of validation documents: Validation Plans, URS, Traceability Matrices; Drafting and execution in the field of test protocols: IQ/OQ/PQ; Drafting of Risk Assessments;: Drafting of computerized system administration procedures; About You: Bachelor's or Master's degree in technical-engineering or similar subjects (Chem...