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Quality engineer - it compliance - pharma

Akkodis
IT
Pubblicato il Pubblicato 13h fa
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PGeneral information /ppPublication date /pp25 / 07 / 2025 /ppCategory /ppOPERATIONS - ENGINEERING / PRODUCTION /ppJob title /ppQuality Engineer - IT Compliance - Pharma /ppContract /ppPermanent contract /ppbJob description /b /ppAkkodis is a global leader in engineering and research development, aiming to accelerate innovation and digital transformation through connected data. /ppWith a passion for technology and talent, the group comprises over 40,000 engineers and digital experts, generating a turnover of 4 billion euros, offering extensive cross-sector experience across 28 countries in North America, EMEA, and APAC. /ppThe Life Sciences division of Akkodis is a leading engineering consultancy in Italy, specializing in validation and GMP services for pharmaceutical, chemical, and healthcare companies. Composed of highly skilled consultants with proven expertise in Good Manufacturing Practices, collaborating with major international companies to ensure compliance with FDA and European standards. Services include Engineering, Commissioning Qualification, IT compliance, Process Quality, Advanced therapies, Training, and GxP. /ppTo strengthen our division, we are looking for a: /ppbQuality Engineer - IT Compliance - Pharma /b /ppJoin our Life Sciences division, which includes over 400 consultants in Italy and approximately 5,000 across Europe. Our strength lies in integrating diverse expertise to provide a comprehensive view of the pharmaceutical industry. /ppbYour contribution at Akkodis /b /ppWithin our IT Compliance team, you will participate in a project to revamp laboratory QC systems at the client's site. /ppThe project involves migrating laboratory instrumentation connected to the IT infrastructure to the OT infrastructure within the manufacturing domain. /ppThe main activities include: /pulliReview of documentation and specifications /liliRisk assessment related to migration /liliUpdating URS /liliValidation protocols creation and execution /liliPreparation of addenda for requalification /liliFinal report issuance /liliUpdating/emission of administration SOPs /li /ulpbBusiness Industry /b /ppLife sciences /ppbProfile /b /ppDegree in a scientific field, preferably in Computer Engineering, Chemical Engineering, or Industrial Chemistry, with at least 2 years of experience in CSV within pharmaceutical environments. /ppYou will join the IT Compliance team within the Life Sciences division, working on projects involving different software technologies and engaging with high-level industrial environments. /ppbAbout you /b /ppbRequirements to start your professional journey: /b /pulliExperience in validation of computerized systems such as ERP, LIMS, and QMS /liliGMP knowledge /liliUnderstanding of FDA CFR 21 Part 11 / EU Annex 11 regulations /liliKnowledge of GAMP5 guidelines /liliExcellent skills in MS Office (Word and Excel) /liliExperience in validation of control systems for industrial automation (PLC, SCADA, DCS) is a plus /liliBasic IT concepts familiarity /liliGood command of written and spoken English (at least B2 level) /liliWillingness to travel /li /ulpbOffer /b /ppPermanent contract /ppbWhat you will find at Akkodis /b /pulliA structured and personalized career path with opportunities for vertical and lateral growth /liliAccess to a Corporate Benefits Platform /li /ulpbLocation /b /ppTerni and Rieti with up to 20% remote work possible /ppJob location /ppEurope, Italy, Lazio /ppLocations /ppRieti and Terni /ppCandidate criteria /ppMinimum education level: Master’s Degree /ppExperience: 1 to 3 years /ppbKey Skills /b /ppDhcp, Active Directory, VMware, Computer Networking, PowerShell, Microsoft Windows Server, Windows, Microsoft Exchange, SAN, Azure, Operating Systems, Dns /ppuEmployment Type : /u Full-Time /ppuExperience : /u 1-3 years /ppuVacancy : /u 1 /p #J-18808-Ljbffr

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