Process & Computer System Validation Specialist (GCP)
2 settimane fa
Process & Computer System Validation Specialist (GCP) Direct message the job poster from Philogen S.p.A. Philogen S.p.A., a biotech company listed on the Milan Stock Exchange and a leader in the development of innovative anti-tumor therapies, is looking for a highly motivated and qualified Process & Computer System Validation Specialist (Gcp) Role The resource will join the QA department and will be responsible for the validation and maintenance of the company’s computerized systems, ensuring compliance with GMP/GCP regulations and quality standards. The role will be pivotal in QA GCP activities , contributing to process compliance and safeguarding data integrity in the clinical environment. Main Responsibilities Validate and maintain computerized systems in line with GxP/GAMP best practices, with a specific focus on GCP. Collaborate with QA and clinical teams to ensure quality and data integrity. Manage validation documentation and draft/review SOPs related to computerized systems and equipment. Participate in internal and external audits concerning validation and QA GCP activities. Provide technical support and contribute to internal training on computerized systems. Requirements Degree in technical/scientific disciplines. At least 2 years of experience in the pharmaceutical sector, preferably with exposure to GCP activities. Knowledge of the computerized systems lifecycle and experience with IQ/OQ/PQ qualifications. Solid understanding of regulatory frameworks: FDA 21 CFR Part 11, EU Annex 11, ISPE GAMP, MHRA, PIC/S. Good command of spoken and written English. Soft Skills Ability to work effectively in multidisciplinary teams. Proactivity, problem‑solving skills, and result orientation. Flexibility, passion for innovation, and strong commitment to quality and safety. Seniority level: Associate Employment type: Full‑time Job function: Other Industries: Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Philogen S.p.A. by 2x Get notified about new Process Specialist jobs in Siena, Tuscany, Italy . We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
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Process & Computer System Validation Specialist (GCP)
2 settimane fa
Borca Di Cadore, Italia Altro A tempo pienoProcess & Computer System Validation Specialist (GCP) Direct message the job poster from Philogen S.p.A.Philogen S.p.A., a biotech company listed on the Milan Stock Exchange and a leader in the development of innovative anti-tumor therapies, is looking for a highly motivated and qualifiedProcess & Computer System Validation Specialist (Gcp)RoleThe resource...
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Process & Computer System Validation Specialist (GCP)
2 settimane fa
Borca Di Cadore, Italia Altro A tempo pienoProcess & Computer System Validation Specialist (GCP)Direct message the job poster from Philogen S.p.A.Philogen S.p.A., a biotech company listed on the Milan Stock Exchange and a leader in the development of innovative anti-tumor therapies, is looking for a highly motivated and qualified Process & Computer System Validation Specialist (Gcp)RoleThe resource...
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Computer System Validation Engineer
14 ore fa
Provincia di Venezia, Italia Meet Life Sciences A tempo pienoJunior Computer System Validation (CSV) Engineer Full Time About the Role 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,...
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Computer System Validation Consultant
3 settimane fa
giuliano di roma, Italia Jobbit A tempo pienoComputer System Validation ConsultantCompany: JobbitLocation: Roma (zona Laurentina), ItalyWork hours: Full time 40 hours per week, Monday to Friday.Contract: Initial 12‑month fixed‑term with a possibility to transition to permanent; CCNL Commercio, 14 monthly payments; pay commensurate with seniority.Job Summary: This role focuses on ensuring that...
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Computer System Validation Consultant
7 giorni fa
Giuliano di Roma, Italia Jobbit A tempo pienoComputer System Validation ConsultantPosizione presso Orienta SpA, Divisione Professionals, per consulenza alle aziende del settore Life Science nella convalida dei sistemi computerizzati (CSV). Sarai responsabile di garantire che i sistemi computerizzati utilizzati in ambiti regolamentati soprattutto farmaceutico, medicale, biotecnologico e chimico siano...
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Computer system validation consultant
1 settimana fa
giuliano di roma, Italia Orienta Filiale di Roma Labicana A tempo pienoOrienta SpA , Divisione Professionals , seleziona per azienda di consulenza alle aziende del settore Life Science nella convalida dei sistemi computerizzati (CSV):1 Computer System Validation ConsultantChe si occuperà di garantire che i sistemi computerizzati utilizzati in ambiti regolamentati soprattutto farmaceutico, medicale, biotecnologico e chimico...
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Computer System Validation Consultant
5 giorni fa
giuliano di roma, Italia Jobbit A tempo pienoComputer System Validation ConsultantPosizione presso Orienta SpA, Divisione Professionals, per consulenza alle aziende del settore Life Science nella convalida dei sistemi computerizzati (CSV). Sarai responsabile di garantire che i sistemi computerizzati utilizzati in ambiti regolamentati soprattutto farmaceutico, medicale, biotecnologico e chimico siano...
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Computer System Validation Consultant
7 giorni fa
Giuliano di Roma, Italia Jobbit A tempo pienoComputer System Validation Consultant Posizione presso Orienta SpA, Divisione Professionals, per consulenza alle aziende del settore Life Science nella convalida dei sistemi computerizzati (CSV). Sarai responsabile di garantire che i sistemi computerizzati utilizzati in ambiti regolamentati soprattutto farmaceutico, medicale, biotecnologico e chimico siano...
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Computerised System Validation Specialist, Prov
2 giorni fa
Provincia di Parma, Emilia-Romagna, Italia MAASI Enterprises A tempo pienoRicerchiamo per la divisione di Advisory e Consulenza alcune figure di **specialist CSV **(Computer System Validation) con esperienza operativa nel settore Life Sciences. **Dettagli della posizione**: - Location: On site Imola (4 posizioni: 1 Senior, 3 Junior/Mid) - Contratto: tempo indeterminato, full time - Riporta a: Project Leader - Livello e...
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System Validation Engineer
1 settimana fa
sant'ambrogio di torino, Italia TurinTech SpA A tempo pienoTurin Tech, società di ingegneria che sviluppa sia progetti interni che in collaborazione con i principali player del settore industriale, principalmente Automotive, Marine, Aerospace & Defence, e Machinery ricerca un: SYSTEM VALIDATION ENGINEERDescrizione del ruoloSiamo alla ricerca di un System Validation Engineer che possa supportare le attività di...
