Copy Of Csv Consultant
2 giorni fa
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 strategic project.Location: LazioResponsibilitiesValidation 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 YouBachelor'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 skillsecosystem that encourages you to step outside your comfort zoneThe opportunity to become a shareholderInvolvement in community and non-profit projectsA dedicated policy to support parenthoodFortil is committed to equal opportunity.All our positions are open to people with disabilities, regardless of gender, origin, or sexual orientation.#J-*****-Ljbffr
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Csv Consultant
5 giorni fa
Lazio, Italia Altro 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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Life Sciences Csv Validation Specialist
2 giorni fa
Lazio, Italia Fortil A tempo pienoAn international engineering and technology consulting group is seeking a CSV Consultant for a strategic project in Lazio, Italy.The role requires 3+ years of CSV project experience in the Life Science sector, along with a Bachelor's or Master's degree in a relevant technical field.Responsibilities include validating computerized systems, drafting validation...
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Senior Csv Consultant – Gmp
5 giorni fa
Lazio, Italia Buscojobs IT C2 A tempo pienoUn'azienda leader nel settore ingegneristico cerca un Senior CSV Consultant a Milano con esperienza nella convalida dei sistemi informatici e competenze in cybersecurity.Il candidato ideale avrà almeno 5 anni di esperienza su sistemi SCADA e ERP, e sarà responsabile della conformità e integrità dei dati.Offriamo prospettive di crescita e l'opportunità...
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Csv Specialist
6 giorni fa
Lazio, Italia Altro A tempo pienoA leading engineering consulting group in Lombardia is seeking a Junior CSV Consultant for the Lifesciences Sector.This role involves validating computerized systems, ensuring compliance with GMP / GxP regulations, and preparing technical documentation.Candidates should have at least 2 years of relevant experience, strong knowledge of regulatory frameworks,...
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Csv Consultant
4 giorni fa
Lazio, Italia Altro A tempo pienoOverviewS4BT è un'Azienda di oltre 90 specialisti e specialiste, che da oltre 30 anni fornisce soluzioni software e consulenze per il settore Life Science e non solo in ambito qualità, ingegneria, Project Management, Validazioni, Tech Transfer, CSV e altro.A supporto della crescita aziendale, ricerchiamo per assunzione a tempo indeterminato un/una...
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Csv Consultant In Ambito Gcp
7 giorni fa
Lazio, Italia Qstep Srl A tempo pienoQStep srl, fondata nel ****, è un'azienda dinamica specializzata nella digital compliance per il settore delle life sciences.Rinomata per il suo approccio innovativo e personalizzato, QStep ha completato con successo diversi progetti relativi alle norme GxP.Supportata da un team multidisciplinare di esperti, l'azienda serve una clientela diversificata, che...
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Lazio, Italia Qstep Srl A tempo pienoUn'azienda dinamica nel settore delle life sciences cerca un consulente CSV per progettazione, implementazione e convalida di sistemi.Il candidato deve avere 2-4 anni di esperienza in GCP e conoscenza delle normative 21 CFR Part 11, oltre a capacità di redazione di documentazione tecnica.Il lavoro è in home base con trasferte presso i clienti per il 70%...
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Proofreader/Copy Editor
7 giorni fa
Lazio, Italia Infuse A tempo pienoProofreader/Copy Editor (Remote, Contract)INFUSE is looking for a detail-oriented Proofreader/Copy Editor.Candidate must be proficient in basic and advanced grammar rules and understand how they are used within our style guides.The ideal candidate is meticulous, noting errors such as punctuation, spelling, and word usage, and checks statements for accuracy...
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Independent/Freelance Gxp Auditor
2 settimane fa
Lazio, Italia Advarra A tempo pienoOverviewAdvarra Consulting seeks independent GxP auditors with experience in clinical research, quality assurance, and related life sciences to perform independent audits across GxP domains (GCP, GCLP, GLP, GMP, GVP, CSV).ResponsibilitiesAuditor Engagements (may include any of the following)CRO AuditsGxP TrainingInspection Readiness Assessment and...
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Senior Csv Consultant
4 giorni fa
Lazio, Italia Buscojobs IT C2 A tempo pienoUn'importante azienda nel settore ingegneristico con sede a Milano cerca un Senior CSV Consultant.Il candidato ideale avrà almeno 5 anni di esperienza nella Computer System Validation e un background nel settore farmaceutico, con competenze in cybersecurity.Avrà il compito di garantire la conformità e l'integrità dei dati, partecipando a Commissioning &...
