Subskrypcja powiadomień powiodła się. Będziesz jednym z pierwszych, którzy dowiedzą się o podobnych zleceniach. Zawsze możesz zmienić wyrażone uprawnienia w ustawieniach przeglądarki.
Responsibilities:
• Responsible for the review of software documentation according to CSV corporate SOP’s, EU and FDA guidance
• Lead and assist project team in the development and approval of computerized systems requirements in accordance with guidance and policy documents
• Lead and author system and functional risk assessments
• Develop/audit new processes and process improvement initiatives
• Implementation and utilization of governance processes and participating in planning system deployment proces
• Observes governance processes, escalates areas for improvement and assists in the implementation and monitoring of solutions
• Develop validation documentation as required and is accountable for entire validation documentation
• Author of validation plans/reports, reviews test plans/reports, summary reports notifying that system is ready to go live
• Coordinates all validation activities on a global level and organizational level for system or project and participates actively in validation discussions
• Provide consultancy for all validation related questions
• Manages defect resolution and testing deviations
Requirements:
• Higher technical education
• Knowledge of GMP
• Experience in a similar position
• Experience in IT Validation
• Experience in the quality maintenance and support of regulated applications
• Experience with project management, CSV, Software Development Lifecycle Models in pharmaceutical industry or related
• Experience leading validation in projects and system maintenance in various areas
• Experience authoring or reviewing test/validation plans, system design documents
• Fluent English in speaking and writing
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
Czy chcesz otrzymywać oferty pracy na podobne stanowiska?