Process & Computer System Validation Specialist (GCP)
Philogen S.p.A.
Process & Computer System Validation Specialist (GCP)
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.
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
#J-18808-LjbffrOfferta di lavoro pubblicata 1 giorno fa
Offerte di lavoro simili
- A leading biotech company in Italy is seeking a highly motivated Process Computer System Validation Specialist (GCP) to join their QA department. The role involves validating computerized systems to ensure compliance with GMP/GCP regulations, contributing to data integrity...ComputerGCPTempo pieno
- ph3Process Computer System Validation Specialist (GCP) /h3 pPhilogen S.p.A., a biotech company listed on the Milan... ...a highly motivated and qualified Process Computer System Validation Specialist... ...of the company’s computerized systems, ensuring compliance with GMP/GCP regulations...ComputerGCP
- ...building, and deploying scalable AI systems for enterprise environments.... ...to support data ingestion, processing, and model training. /pp•... ...Bachelor's or advanced degree in Computer Science, Engineering, or a... ...cloud platforms (e.g., AWS, GCP, Azure) and MLOps tools for model...ComputerGCPTempo pienoRemoto
30.000 € - 45.000 €
...ricerca di un bERP/ /b bSAP Validation Consultant /b con... ...supportare PQE nei processi di compliance regolatoria quali la Computer System Validation presso la nostra... ...standard di qualità e validazione del settore... ...Regulatory Affairs e Process Owners durante le fasi...ComputerImpiego permanenteDal lunedì al venerdì2 giorni/sett.Weekend- ...Incident Response experience (investigations for targeted threats) Computer Forensic Analysis background with various forensic tools... ...remediation plans Cloud Incident Response knowledge (AWS, Azure, GCP) Strong communications to executives, clients, and internal...ComputerGCPRemoto
- ...platform services Automate system security practices (patching,... ...as SME, collaborating with IT Systems, CloudOps, Security, and Engineering... ...Bachelor's degree in Computer Science or 8+ years of equivalent... ...networking) and knowledge of AWS/Azure/GCP and Kubernetes Hands‐on...ComputerGCPLavoro ibridoRemotoLavoro da casaOrario flessibile
- ...continuous improvement, with opportunities to influence both support processes and product direction. Retribuzione / Benefits Extra days... .../python) ~ Knowledge of public cloud providers (AWS, Azure, GCP) ~ Strong problem-solving and diagnostic abilities ~...GCP
- ...Lavorerai nel cluster Technology e supporti i team di sviluppo e operations nell’integrazione della sicurezza nei processi CI/CD. /ppRichiesta esperienza con AWS/Azure/GCP, conoscenza dei principi di Cloud Foundation, CIS e NIST, e certificazioni tra Azure/AWS/GCP. /p #J-18808-...GCP
- ...di sviluppo e operations nell’integrazione della sicurezza nei processi CI/CD. Selezioni e implementi controlli di sicurezza, automatizzando... ...come Cloud Security Architect /liliEsperienza con AWS, Azure o GCP /liliConoscenza dei principi di Cloud Foundation /liliEsperienza...GCP
42.044,86 € - 46.403,24 €
...liCollaborare con Qualità e Affari Regolatori per sviluppare e mantenere processi e procedure cliniche FBS. /li liCollaborare attivamente con... ...ed internazionali, rispettando tempi, costi e standard GCP/FBS. /li liPreparare, monitorare e gestire i budget degli studi...GCPTempo determinato- ...containerization, and automated delivery processes Integrate services, APIs, and infrastructure... ...the design and evolution of cloud-native systems and DevOps pipelines Requisiti... ...CI/CD, and cloud platforms (AWS, Azure, GCP) Strong teamwork and ability to explain...GCP
- ...the surroundings. The captured data will be stored on onboard computers (SSD Drives) and later utilized to enhance one of the world’s leading... ...standard business hours (8 AM - 7 PM). The recruitment process for the position of a Driver involves such steps: safety...ComputerTempo pieno
- ullibRole /b: Machine Learning Engineer - Computer Vision (Remote) /lilibLocation /b:... ...series forecasting, and natural language processing. /pp• Expertise in Python and core libraries... ...development of proprietary intelligence systems that drive measurable business impact....ComputerRemoto
- ...contribute to automating infrastructure processes and optimize delivery across the full solution... ...'s degree in a relevant engineering/computer science field (as stated) Experience... ...VMware, Kubernetes, containers, and Linux systems Knowledge of virtualization and...ComputerRemoto
- ...per trasformare ricerca e innovazione in soluzioni pratiche per i processi aziendali. Svilupperai architetture end-to-end, governance dei... ...Pandas, ETL) ~ Esperienza su almeno un cloud provider (Azure, AWS o GCP) e relativi servizi dati (Synapse/ADF, Glue/Redshift, BigQuery/...GCP
- ...Marchesini Group S.p.A. cerca un Addetto alle Specifiche Funzionali da inserire nel team Validazioni. Il ruolo prevede di seguire il processo di validazione durante le fasi della commessa, redigere la documentazione tecnica e supportare il cliente durante collaudo e post...
- ...skills. /liliKnowledge of the principles and processes for providing personalized services... ...service standards, alternative delivery systems, and guest satisfaction evaluation techniques... ...evaluating skills. /liliIntermediate computer software skills required. /liliPossess a...Computer
- ...innovazione, leadership tecnica e impatto sui processi aziendali, con una forte focalizzazione... ...(Generative AI, Agentic Workflows, Edge Computing, Service Mesh) nell'offerta e nelle... ...architetture Cloud avanzate (Azure, AWS o GCP) e Kubernetes enterprise ~ Esperienza in...GCPLavoro ibrido
- ...knowledge of the national and regional health system ~ Leadership of relationships with key... ...native and English proficient ~ Computer Skills: proficient in Microsoft Office Suite... ...regulations and market access processes ~ Ability to work collaboratively in cross...Computer
- ...maintenance of core financial systems. The role involves designing and... ...transactions and data processing. /ppbr/ppbKey Responsibilities... ...minimize downtime and ensure system reliability. /ppbr/ppbRequired... ...Knowledge of cloud platforms (AWS, GCP, or Azure) and containerization...GCPTempo pienoRemoto
- ...Operazioni Cliniche e interfacciarsi con Qualità, Regolatori ed EVH. È richiesta esperienza avanzata in studi clinici e conoscenza CTR/ICH-GCP. /ppLa posizione prevede responsabilità di pianificazione, budgeting, supervisione e interazione con comitati etici, per studi...GCP
- ...sourcing, screening, and engagement processes. The position requires deep... ...in machine learning and AI systems while collaborating with cross... ...Familiarity with cloud platforms (AWS, GCP, or Azure) and... ...on a cutting-edge AI recruiter system used by organizations worldwide...GCPRemoto
27.000 € - 35.000 €
...destinate al settore bHealthcare /b: medical systems, servizi e tecnologie con intelligenza... ...del server nonchè un presidio dei processi e delle procedure tecniche. /ppbr/ppIl/la... ...configurazione hardware e software per server, reti, computer e periferiche; /lilifamiliarità con le...ComputerImpiego permanenteRemoto- ...powered experience orchestration Lead process-redesign workshops to achieve seamless, channel... ...with customer CRM/ERP and third-party systems Establish KPIs and analytics to... ...pipelines, and cloud environments (AWS, Azure, GCP) ~ Mentoring experience and ability to...GCPOrario flessibile
- ...to support high-availability systems for intralogistics solutions.... ...(WebLogic, WildFly) Apply system upgrades/patches on customer... ...recommendations Adhere to Swisslog processes and standards Requisiti... ...in information technology, computer science or equivalent...ComputerLavoro ibridoRemotoOrario flessibile
- ...pipelines to streamline software delivery processes. This position requires collaboration... ...Terraform, Ansible, or similar tools. Monitor system performance, troubleshoot issues, and... ...on platforms such as AWS, Azure, or GCP, ensuring scalability and cost optimization...GCPTempo pieno
- ...the surroundings. The captured data will be stored on onboard computers (SSD Drives) and later utilized to enhance one of the world’s leading... ...intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing...Computer
- ...bBattery Energy Storage Systems (BESS) /b. Our... ...our Energy Management System and our backend services... ...will be responsible for processing, preparing, and integrating... ...completed degree in Computer Science, Electrical... ...fast decision-making processes, and room for your own...Computer
- ...pipelines to streamline software delivery processes. This position requires collaboration... ...Ansible, or similar tools. /li /brliMonitor system performance, troubleshoot issues, and implement... ...on platforms such as AWS, Azure, or GCP, ensuring scalability and cost...GCPTempo pieno
- ...captured data will be stored on onboard computers (SSD Drives) and later utilized to enhance... ...hours (8 AM - 7 PM). /p pbThe recruitment process for the position of a Driver involves... ...process. /p h3Ideal Candidate /h3 ul liHolds a valid EU-issued driver’s license. /li...ComputerTempo pieno