CSV Consultant
2 settimane fa
CSV Consultant (Monza) Role at fortil Location: Monza. 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. 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? Personalized support to help you grow your skills; An ecosystem that encourages you to step outside your comfort zone; The opportunity to become a shareholder; Involvement in community and non-profit projects; A dedicated policy to support parenthood; Seniority Level Mid-Senior level Employment Type Full-time Job Function Consulting, Information Technology, and Sales Industries Business Consulting and Services Fortil is committed to equal opportunity. All our positions are open to people with disabilities, regardless of gender, origin, or sexual orientation. #J-18808-Ljbffr
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CSV Consultant
4 settimane fa
Milano, Italia Altro A tempo pienoCSV Consultant (Monza) Role at fortil Location: Monza. 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...
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CSV Consultant
7 ore fa
Milano, Lombardia, Italia fortil A tempo pienoortil 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 aCSV Consultantfor a strategic...
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Csv Consultant
6 giorni fa
Milano, Italia Fortil A tempo pienoCSV Consultant (Monza)Role at fortilLocation: Monza.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 aCSV Consultantfor a...
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Junior Csv Consultant
2 settimane fa
Milano, Italia Abylsen A tempo pienoABYLSEN is an international engineering consulting group with **** employees and a turnover of 290 M€ in ****.Created by a number of entreprenors in ****, the group was born from a common development ambitions across the major European regions and is now located in 30 locations spread over 7 countries (France, Italy, Switzerland, Spain, Luxembourg, Belgium...
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Junior Csv Consultant
2 settimane fa
Milano, Italia Abylsen A tempo pienoABYLSEN is an international engineering consulting group with **** employees and a turnover of 290 M€ in ****.Created by a number of entreprenors in ****, the group was born from a common development ambitions across the major European regions and is now located in 30 locations spread over 7 countries (France, Italy, Switzerland, Spain, Luxembourg, Belgium...
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CSV Consultant
2 settimane fa
Milano, Italia fortil A tempo pienoCSV Consultant (Lombardia) 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. Location: Lombardia. Responsibilities Validation of computerized...
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CSV Validation Specialist
2 settimane fa
Milano, Italia fortil A tempo pienoAn engineering and consulting group in Lombardia is seeking a CSV Consultant. The successful candidate will validate computerized systems in the Life Science sector, manage remediation projects, and draft validation documents. A Bachelor's or Master's degree in a relevant field and 3+ years of experience in CSV projects are essential. The role offers...
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CSV Validation Specialist – Life Sciences
2 settimane fa
Milano, Italia fortil A tempo pienoA global consulting firm is seeking a CSV Consultant based in Monza. This role involves validating computerized systems in the Life Science sector and supporting compliance with regulatory standards. Candidates should hold a relevant degree and have over 3 years of experience in CSV projects. The position offers opportunities for professional growth,...
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Computer System Validation
6 giorni fa
Milano, Italia Buscojobs IT C2 A tempo pienoIl nostro cliente, con sede a Milano, è un player con alto posizionamento nell'ingegneria, convalida e quality assurance per sistemi, apparecchiature e impianti, sia nuovi che esistenti.Fornisce inoltre servizi di auditing, testing, commissioning e convalida di sistemi automatizzati, conformi ai più elevati standard internazionali.Stiamo cercando un Senior...
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Computer System Validation
6 giorni fa
Milano, Italia Buscojobs IT C2 A tempo pienoL'AZIENDAIl nostro cliente, con sede a Milano, è un player con alto posizionamento nell'ingegneria, convalida e quality assurance per sistemi, apparecchiature e impianti, sia nuovi che esistenti. Fornisce inoltre servizi di auditing, testing, commissioning e convalida di sistemi automatizzati, conformi ai più elevati standard internazionali.IL RUOLOStiamo...
