Process & Computer System Validation Specialist (Gcp)
5 giorni fa
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 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 ResponsibilitiesValidate 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.RequirementsDegree 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 SkillsAbility to work effectively in multidisciplinary teams.Proactivity, problem-solving skills, and result orientation.Flexibility, passion for innovation, and strong commitment to quality and safety.
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Computer System Validation
4 settimane fa
Provincia di Milano, Italia agap2 Italia A tempo pienoComputer System Validation (CSV) Specialist – Sede: Milano Tipo di Impiego : Full Time La risorsa sarà inserita nel team Quality/Compliance e si occuperà delle attività di convalida e qualificazione dei sistemi informatici utilizzati in ambito GxP (farmaceutico, medical device o biotech). Supporterà i progetti IT e Quality garantendo la conformità...
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Computer System Validation Consultant
4 giorni 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
4 giorni 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
3 giorni fa
Giuliano di Roma, Italia Jobbit A tempo pienoComputer System Validation Consultant Company: Jobbit Location: Roma (zona Laurentina), Italy Work 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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System Validation Engineer
4 settimane fa
Casalnuovo di Napoli, Italia Altro A tempo pienoSystem Validation Engineer role at Hitachi RailA career at Hitachi Rail will help create a legacy. With operations in every corner of the world, our work goes to the cutting‑edge of digital transformation and technology. From the multicultural strength of our global organization to the sustainable and innovative ways we work to bring people together,...
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Computer System Validation Consultant
4 settimane fa
Provincia di Roma, Italia Information & Communication Technology A tempo pienoArea: Information & Communication Technology Data: 23/11/2025 Orienta Orienta SpA, Divisione Professionals, seleziona per azienda di consulenza alle aziende del settore Life Science nella convalida dei sistemi computerizzati (CSV): 1 Computer System Validation Consultant che si occuperà di garantire che i sistemi computerizzati utilizzati in ambiti...
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Informatico Computer
4 settimane fa
Provincia di Milano, Italia agap2 Italia A tempo pienoComputer System Validation (CSV) Specialist – Sede: Milano Tipo di Impiego : Full Time La risorsa sarà inserita nel team Quality/Compliance e si occuperà delle attività di convalida e qualificazione dei sistemi informatici utilizzati in ambito GxP (farmaceutico, medical device o biotech). Supporterà i progetti IT e Quality garantendo la conformità...
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System Validation Engineer
4 settimane fa
Casalnuovo di Napoli, Italia Informatica Software A tempo pienoAbout UsA career at Hitachi Rail will help create a legacy. With operations in every corner of the world, our work goes to the cutting-edge of digital transformation and technology. From the multicultural strength of our global organisation to the sustainable and innovative ways we work to bring people together, there’s something for everyone to get stuck...
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System Validation Engineer
4 settimane fa
Casalnuovo di Napoli, Italia Altro A tempo pienoLocation:Naples, Campania, ItalyJob ID:R Date Posted:Company Name:HITACHI RAIL STS S.P.A.Profession (Job Category):OtherJob Schedule:Full timeRemote:NoAbout UsA career at Hitachi Rail will help create a legacy. With operations in every corner of the world, our work goes to the cutting‑edge of digital transformation and technology. From the multi‑cultural...
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System Validation Engineer
4 settimane fa
Napoli, Italia Hitachi Rail A tempo pienoSystem Validation Engineer role at Hitachi Rail A career at Hitachi Rail will help create a legacy. With operations in every corner of the world, our work goes to the cutting‑edge of digital transformation and technology. From the multicultural strength of our global organization to the sustainable and innovative ways we work to bring people together,...
