COMPUTER SYSTEM VALIDATION

7 giorni fa

verona, Italia Orienta A tempo pieno

Orienta Spa, Società Benefit filiale di Verona , ricerca per società di consulenza un/una: COMPUTER SYSTEM VALIDATION & DATA INTEGRITY CONSULTANT GMP Mansioni La risorsa verrà inserita in progetti presso aziende farmaceutiche e produttori di API, con focus sul mondo GMP .Si occuperà di attività di convalida e gestione documentale in ambito software, sistemi di produzione e laboratori QC. In particolare: Esecuzione di assessment GMP su sistemi computerizzati e processi digitali Redazione della documentazione di convalida: URS, Risk Assessment, Validation Plan, IQ/OQ/PQ, SOP Monitoraggio della compliance dei sistemi rispetto ai requisiti normativi (EU GMP Annex 11, FDA 21 CFR Part 11) Analisi e implementazione dei principi di Data Integrity  (ALCOA+) Supporto alla gestione delle deviazioni, change control e CAPA relativi ai sistemi informatizzati Verifica periodica dei sistemi e stesura reportistica di stato Collaborazione con QA, IT, Produzione e QC per garantire la piena conformità GMP Requisiti Laurea in discipline scientifiche (CTF, Biotecnologie, Chimica, Ingegneria o equivalenti) Esperienza precedente in ambito CSV in contesti GMP Conoscenza delle normative farmaceutiche europee e FDA Capacità di analisi, precisione e gestione documentale Ottime competenze comunicative e attitudine alla consulenza Soft Skills Problem solving e orientamento al cliente Capacità di lavorare in team multidisciplinari Autonomia operativa Riservatezza e attenzione al dettaglio Si propone: Inserimento diretto in azienda CCNL applicato: Chimica Industria * 13 mensilità Orario di lavoro: Full-time 40 ore dal lunedì al venerdì L'orario di lavoro prevede il 70% in smart working, mentre il restante 30% sarà dedicato ad attività in sede e presso i clienti assegnati per il monitoraggio dei progetti. Per i candidati residenti a Verona o nelle zone limitrofe, è richiesta una presenza in ufficio pari al 50% Sedi di lavoro indicative: VERONA - PARMA- PADOVA - MILANO by helplavoro.it

  • Computer System Validation

    2 settimane fa

    Verona, Italia Orienta A tempo pieno

    Orienta Spa - Società Benefit, filiale di Verona, ricerca per azienda cliente specializzata nei servizi di Data Integrity, Computerized System Validation e IT Governance & Compliance un/a **Computer System Validation & Data Integrity Consultant** La figura inserita in organico si dedicherà alle seguenti mansioni: - Stesura Validation Plan e Validation...

  • Computer System Validation Engineer

    2 settimane fa

    Verona, Italia Meet Life Sciences A tempo pieno

    Junior Computer System Validation (CSV) Engineer Full Time We are seeking a Junior / Entry-Level Computer System Validation (CSV) Engineer with a Biomedical Science (or closely related life science) degree and a genuine passion for computer science, systems, and technology . This role is ideal for someone who understands biology, laboratories, and...

  • Junior Computer System Validation

    2 settimane fa

    Verona, Italia Meet Life Sciences A tempo pieno

    Junior Computer System Validation (CSV) Engineer Location: Verona, ItalyFull TimeAbout the RoleWe are seeking a Junior / Entry-Level Computer System Validation (CSV) Engineer with a Biomedical Science (or closely related life science) degree and a genuine passion for computer science, systems, and technology .This role is ideal for someone who understands...

  • Junior Computer System Validation

    2 settimane fa

    Verona, Italia Meet Life Sciences A tempo pieno

    Junior Computer System Validation (CSV) EngineerLocation: Verona, ItalyFull TimeAbout the RoleWe are seeking a Junior / Entry-Level Computer System Validation (CSV) Engineer with a Biomedical Science (or closely related life science) degree and a genuine passion for computer science, systems, and technology .This role is ideal for someone who understands...

  • Junior Computer System Validation

    2 settimane fa

    Verona, Italia Meet Life Sciences A tempo pieno

    Junior Computer System Validation (CSV) Engineer?? Location: Verona, Italy ?? Full Time?? About the RoleWe are seeking a Junior / Entry-Level Computer System Validation (CSV) Engineer with a Biomedical Science (or closely related life science) degree and a genuine passion for computer science, systems, and technology.This role is ideal for someone who...

  • Junior computer system validation

    2 settimane fa

    Verona, Italia Meet Life Sciences A tempo pieno

    Junior Computer System Validation (CSV) EngineerLocation: Verona, ItalyFull TimeAbout the RoleWe are seeking a Junior / Entry-Level Computer System Validation (CSV) Engineer with a Biomedical Science (or closely related life science) degree and a genuine passion for computer science, systems, and technology .This role is ideal for someone who understands...

  • Junior Computer System Validation

    2 settimane fa

    Verona, Italia Meet Life Sciences A tempo pieno

    Junior Computer System Validation (CSV) EngineerLocation: Verona, ItalyFull TimeAbout the RoleWe are seeking a Junior / Entry-Level Computer System Validation (CSV) Engineer with a Biomedical Science (or closely related life science) degree and a genuine passion for computer science, systems, and technology.This role is ideal for someone who understands...

  • Junior Computer System Validation

    2 settimane fa

    Verona, Italia Meet Life Sciences A tempo pieno

    Junior Computer System Validation (CSV) Engineer📍 Location: Verona, Italy 🕒 Full Time🔹 About the RoleWe are seeking a Junior / Entry-Level Computer System Validation (CSV) Engineer with a Biomedical Science (or closely related life science) degree and a genuine passion for computer science, systems, and technology.This role is ideal for someone who...

  • Junior Computer System Validation

    2 settimane fa

    Verona, Italia Meet Life Sciences A tempo pieno

    Junior Computer System Validation (CSV) EngineerLocation: Verona, ItalyFull TimeAbout the RoleWe are seeking a Junior / Entry-Level Computer System Validation (CSV) Engineer with a Biomedical Science (or closely related life science) degree and a genuine passion for computer science, systems, and technology.This role is ideal for someone who understands...

  • Junior Computer System Validation

    2 settimane fa

    Verona, Italia Meet Life Sciences A tempo pieno

    Junior Computer System Validation (CSV) Engineer ?? Location: Verona, Italy?? Full Time?? About the RoleWe are seeking a Junior / Entry-Level Computer System Validation (CSV) Engineer with a Biomedical Science (or closely related life science) degree and a genuine passion for computer science, systems, and technology.This role is ideal for someone who...