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: Bologna 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); 3+ 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; Why join us? At Fortil, we implement
concrete initiatives to support your development and ensure an
inspiring work environment

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