CSV Engineer Belgium
Il y a 5 heures
belgium belgium
Resourcing Life Science Ltd.
Temps plein
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ph3Responsibilities /h3ulliWork with relevant Change Owners for all GxP IT systems to identify and mitigate risks, ensuring all changes are tracked to completion. /liliPrepare and execute core CSV deliverables, including validation protocols, summary reports, and periodic system reviews. /liliProvide technical assessment and system support for quality deviations and non-conformances. /liliRecommend and manage Corrective and Preventive Actions (CAPAs) to enhance system compliance and performance. /liliAuthor and maintain SOPs and work instructions governing the operation, maintenance, and compliance of software systems. /liliCollaborate with IT and process owners to ensure the compliance of software systems throughout the entire system lifecycle. /liliEnsure adherence to CSV procedures during system implementations and provide support for new software projects, including updates to the validation master plan. /liliServe as the subject matter expert for CSV during internal and external regulatory audits. /liliCoordinate with the Validation department to align CSV processes with broader site validation policies and standards. /liliResearch and propose the implementation of new technologies to improve business and compliance processes. /li /ulh3Key Requirements /h3ulliProven professional experience within a Pharmaceutical, Life Science, or similarly regulated GxP environment. /liliExtensive background in Computer Systems Validation (CSV) or a higher education qualification in Computer Science or a related technical discipline. /liliStrong understanding of IT Infrastructure and Networks. /liliPractical knowledge of IT Qualification (IQ) activities and documentation. /liliFamiliarity with industry standards such as GAMP 5 and Data Integrity regulations. /li /ulpIf you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) or email /p /p