- Support validation activities;
- Collaborates on the evaluation of the changes to the computerized systems from a regulation and data integrity requirements perspective;
- Collaborates on the investigation and resolution of compliance issues that may arise (Deviation and CAPA).
- Verify if a computerized system is designed according to the applicable regulatory and data integrity requirements: review of User Requirements and Software Specifications;
- Collaborates on the delivering of the Computerized Systems validation documents;
- Collaborates to ensure that the system is maintained in the validated status along with its lifecycle, and its validation documentation up-to-date. Deal with the process of "periodic review" of the relevant computerized systems.
- Maintains updated the EUBPT computerized systems "Inventory List";
- Collaborates with internal/supplier audit team during audit in GAMP area.
- Experiences in Quality area with knowledge on:
- Computer systems related quality processes (e.g. Change Control, Deviation, CAPA);
- Computer System Compliance and Validation Life Cycle;
- CFR Part 11 and EU GMP Annex 11 principles;
- experiences in IT areas with knowledge on computerized systems typically used in Pharma Laboratory environments or equivalent working areas.
- Computerized system to analytical laboratory (e.g. CDS, LIS, LIMS);
- GAMP guidance;
- GMP Regulation for computer system (EU GMP-volume 4 annex 11; CFR21 part 11) and pharma industry (EU GMP volume 4, CFR21 part 210, 211);
- Data governance and data Integrity principle;
- Problem solving;
- Team working/working together;
- Precision and control;
- Flexibility: planning and organizing.
- Possibility of Smart Working;
- Flexible schedule;
- Ticket Restaurant €8/day;
- Professional development support.
-
Validation Specialist
Trovato in: Buscojobs IT C2 - 3 ore fa
Jefferson Wells Varese, Italia A tempo pienoPer azienda operante nel settore dell'ingegneria industriale per il mondo farmaceutico, Jefferson Wells è alla ricerca di una figura di: VALIDATION SPECIALIST · SCOPO DELLA POSIZIONE · Il ruolo, inserito in ambito CPS, ha lo scopo di:Essere lo specialista per la preparazione e l' ...
-
Process and Cleaning Validation Specialist
Trovato in: Talent IT C2 - 1 giorno fa
Thermo Fisher Scientific Monza, Italia A tempo pienoThermo Fisher Scientific, World Leader nel servire la Scienza, sta cercando per il suo Gruppo di Qualità nel sito di Monza un . · SCOPO DELLA POSIZIONE/RESPONSABILITÀ: · Supportare il Process & Cleaning Validation Team Leader nell'assicurare la convalida dei processi aziendali r ...
-
Testing Verification And Validation Specialist
Trovato in: Buscojobs IT C2 - 3 giorni fa
3Ecruit Milano, ItaliaTesting Verification and Validation SpecialistWe are seeking a qualified and motivated professional to join our team in the role of Testing, Verification, and Validation Specialist, with a specific emphasis on industrialisation. In this capacity, you will be tasked with defining ...
-
IT Support Specialist
Trovato in: Talent IT C2 - 5 giorni fa
Eurofins Vimodrone, Italia A tempo pienoJob Description · Eurofins BioPharma Product Testing is seeking an experienced, versatile and highly skilled IT Support Specialist to join our Team Europe based in Vimodrone (MI). · This position requieres business travel to other sites if needed. · Overall Objectives: · A ...
-
IT Support Specialist
Trovato in: Talent IT C2 - 6 giorni fa
Eurofins Italy BioPharma Product Testing Vimodrone, Italia A tempo pienoJob Description · Eurofins BioPharma Product Testing is seeking an experienced, versatile and highly skilled IT Support Specialist to join our Team Europe based in Vimodrone (MI). · This position requieres business travel to other sites if needed. · Overall Objectives: · Assist w ...
-
Order Management Specialist – Spanish Speaker
Trovato in: Buscojobs IT C2 - 3 giorni fa
Triumph International Segrate, ItaliaBrand Vacancy title Order Management Specialist – Spanish speaker Ref 20563 Function Sales Europe City Segrate Salary Competitive Closing date 14/05/2024 Description Triumph Group joins the ranks of global leaders in the lingerie sector, with a multi-facetted product palette that ...
-
Order Management Specialist
Trovato in: Buscojobs IT C2 - 4 giorni fa
Triumph International Segrate, ItaliaBrand Vacancy title Order Management Specialist – Spanish speaker Ref 20563 Function Sales Europe City Segrate Salary Competitive Closing date 14/05/2024 Description Triumph Group joins the ranks of global leaders in the lingerie sector, with a multi-facetted product palette that ...
-
Field Technical Support Specialist
Trovato in: Appcast IT BE DE A2 - 6 giorni fa
Danaher Monza, Italia A tempo pienoWondering what's within Beckman Coulter Diagnostics? Take a closer look. At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supporte ...
-
Field Technical Support Specialist
Trovato in: beBee S2 IT - 4 giorni fa
Danaher Cassina De' Pecchi, Italia A tempo pienoWondering what's within Beckman Coulter Diagnostics? Take a closer look. · At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be suppor ...
-
sterility assurance specialist
Trovato in: Jobatus IT A2 - 5 giorni fa
Pharma Point Srl Milano, ItaliaPer un conto di una importante CDMO farmaceutica siamo alla ricerca di un/una: Sterility Assurance Specialist Principali responsabilità: Gestisce il programma di aseptic process simulation (APS) Supporta i reparti di process ed equipment validation nelle attività di convalida ine ...
-
It Security Specialist
Trovato in: Buscojobs IT C2 - 2 giorni fa
Hunters Group Milano, ItaliaL'azienda che stiamo supportando nella ricerca è uno tra i maggiori player in ambito assicurativo, pagamenti digitali e moneta elettronica. Principali responsabilità Stiamo ricercando un/una IT Security Specialist da inserire nella divisione IT. La risorsa dovrà assicurare l'impl ...
-
qa specialist
Trovato in: Talent IT C2 - 23 ore fa
Adhr Milan, ItaliaHealthcare & Pharma di ADHR Group, specializzata nella selezione di professionisti nel settore sanitario e farmaceutico, ricerca per prestigiosa azienda leader nel settore farmaceutico un/a: · QA Specialist · Le mansioni principali includono: · Definizione e redazione dei Protoco ...
-
Hotel Assessor "Mystery guest"
Trovato in: Talent NL C2 - 4 giorni fa
Ecolab Milan, Italia Tempo parzialeJOB DESCRIPTION EcoSure - a division of Ecolab and an industry leader in quality-assurance examinations for various brand assurance programs. Our specialists are unique safety experts on whom our clients in the hospitality industry rely. We are looking for professionals to prov ...
-
Penetration Tester
Trovato in: Buscojobs IT C2 - 2 giorni fa
Tn Italy Milano, Italiacol-wideJob Description:Siamo una società italiana di technology consulting con sedi a Torino e Milano. Operiamo su tutto il territorio nazionale e in Svizzera, offrendo servizi di consulenza, soluzioni e progetti per la digital trasformation e per la cybersecurity.Siamo guidati ...
-
Penetration Tester
Trovato in: Talent IT C2 - 3 ore fa
ISCS Milan, ItaliaSiamo una società italiana di technology consulting con sedi a Torino e Milano. Operiamo su tutto il territorio nazionale e in Svizzera, offrendo servizi di consulenza, soluzioni e progetti per la digital trasformation e per la cybersecurity. · Siamo guidati da un'anima Digital e ...
-
Technology Specialist Manager
Trovato in: Talent IT C2 - 3 ore fa
Microsoft Milan, Italia A tempo pienoOverview · The Technical Specialist Manager in Business Applications is responsible for leading a team of customer-focused Technical Specialists. This role is focused on empowering digital transformation and providing clear demonstrations of how Dynamics 365 can unlock business ...
-
IT Digital Application Specialist
Trovato in: Talent IT C2 - 3 giorni fa
Moncler Spa Milan, ItaliaFor our Moncler IT Dept. we are looking for an IT Digital Application Specialist to join the IT Digital Team based at our HQ in Milan. · Your impact · The IT Digital Application Specialist, reporting to the Omnichannel Application Architect Manager, will collaborate with ecomm ...
-
Senior Payroll Specialist
Trovato in: Appcast US A2 ECP - 5 ore fa
ADP Milano, Italia Not SpecifiedJOB TITLE: Senior Payroll Specialist · LOCATION: ADP Italy · REPORTS TO: Production Team Manager · JOB PURPOSE: · To maximise value for clients by: · Single Point of Contact · Rapidly resolving client queries in response to phone calls, CRM and emails · Continuously improving ...
-
Junior Field Engineering Specialist
Trovato in: Jooble IT O C2 - 3 giorni fa
3ECRUIT Lombardia, ItaliaJunior Field Engineering Specialist · We are in search of an energetic individual to join our team as a Junior Field Engineering Specialist. This role is ideal for someone who is keen to immerse themselves in technical fieldwork, problem-solving, and providing support for proje ...
-
Engineer III, Field Service
Trovato in: Talent IT C2 - 1 giorno fa
Thermo Fisher Scientific Milan, Italia A tempo pieno: The Field Service Engineer (FSE) will conduct instrument repairs, upgrades, installation, and preventative maintenance at customer sites. The FSE will primarily handle an assigned Service Territory, but will provide service in other territories as needed. · A day in the Life ...
Computer System Validation Specialist - Vimodrone, Italia - Eurofins
Descrizione
Job Description
Eurofins BioPharma Product Testing (BPT) is looking for its site in Vimodrone (MI) a Computer System Validation Specialist that will collaborate with the European CSV Coordinator to assure the GMP compliance requested for all the computerized systems in use in the Eurofins European Biopharma Product Testing . The role will report to the Quality and Compliance Director.
Main tasks:
Qualifications
Professional Experience
Professional Knowledge
Managerial Skills
Additional Information
The type of contract will be assessed on the basis of the candidate's profile.
To apply, it is necessary send a detailed Curriculum Vitae, specifying the authorization to process personal data. CVs without these requirements will not be considered.
To learn more about Eurofins, please explore our website ,
