Senior Computer System Validation (CSV) Consultant

Fortil is an engineering consulting group active across Europe since 2009.

We are seeking a Senior Computer System Validation (CSV) Consultant to join our growing team in Frosinone .

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 (Chemical Engineering, Chemistry, Industrial Chemistry, Mechanical Engineering, CTF, Pharmacy, Biology);
• 5+ years of experience on CSV projects in the Life Science field;
• Skilled in mapping data flows and performing gap analyses to identify compliance and process improvement opportunities;
• Good knowledge of the reference regulations and guidelines. In particular, knowledge of GMP, CFR 21 Part 11 Regulations, EU/GMP Annex 11, ISPE GAMP5; guidelines, data integrity regulations and guidelines (e.g. MHRA, WHO, EMA, FDA) and ICH guidelines, in particular ICHQ9, is required;
• Good knowledge of the English language, both written and spoken;
• Excellent knowledge of the Office package;