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 #J-18808-Ljbffr
CSV Engineer Switzerland Arbeitgeber: Resourcing Life Science
Als Arbeitgeber im Bereich der medizinischen Geräte bietet unser Unternehmen eine dynamische und unterstützende Arbeitsumgebung, in der Mitarbeiter die Möglichkeit haben, ihre Fähigkeiten durch Schulungen und den Austausch mit Fachleuten kontinuierlich zu erweitern. Wir fördern eine Kultur des Wachstums und der Zusammenarbeit, in der jeder Beitrag geschätzt wird und die Beziehungen zu wichtigen Meinungsführern in der Gesundheitsbranche im Mittelpunkt stehen. Darüber hinaus profitieren unsere Mitarbeiter von flexiblen Arbeitszeiten und der Möglichkeit, an bedeutenden Fachmessen und Kongressen teilzunehmen, was die berufliche Entwicklung und Vernetzung fördert.
