QA-CSV Specialist

Il y a 2 heures
Beerse, Flanders, Belgique Pauwels Consulting Temps plein
pOur client, a leading life sciences organization, is seeking a specialist to provide quality oversight and functional governance for computerized systems. The role combines independent QA-CSV validation support for manufacturing automation with the site-wide implementation of a digital checklist management system. /p ul liProvide independent bQA-CSV /b oversight for projects, changes, and operations within a bGxP /b environment. /li liReview and approve validation deliverables, including risk assessments, specifications, and summary reports. /li liAssess changes, deviations, and bCAPAs /b for impact on product quality and data integrity. /li liCoordinate the digitalization of paper-based processes into controlled digital workflows and checklists. /li liGovern user access and system roles to ensure compliance with business needs and segregation of duties. /li liMonitor system metrics and ensure records are closed within acceptable timelines. /li liProvide functional guidance and support to stakeholders across the site. /li /ul ul liBachelor or Master degree in bEngineering /b, bAutomation /b, bComputer Science /b, or bLife Sciences /b. /li li3+ years of relevant experience in bCSV /b, bvalidation /b, and bquality assurance /b within a bGxP /b-regulated environment. /li liPractical experience with lifecycle documentation, bchange control /b, bdeviation management /b, and bCAPA /b. /li liKnowledge of bSDLC /b, bEU GMP Annex 11 /b, bUS FDA 21 CFR Part 11 /b, bGAMP 5 /b, and bdata integrity /b principles. /li liStrong collaboration and organization skills with a solution-oriented approach. /li liYou are fluent in bEnglish /b. /li /ul h3bNice to Haves /b /h3 ul liExperience with bPLC /b, bSCADA /b, industrial automation networks, or binfrastructure monitoring /b. /li liFamiliarity with digital workflow or electronic form management solutions. /li liKnowledge of bDutch /b. /li /ul

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