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CSV Consultant
Eingestellt von Alexandra Paul Recruitment LLP
Gesuchte Skills: Consultant, Engineering
Projektbeschreibung
CSV Consultant
Three plus (3+) years' experience within a dedicated a CSV or product software validation role. Proficient in system and software validation engineering processes, software risk management, software V&V methodologies, and software configuration management.
Understanding of GAMP5 and risk-based approach to validation is required
Three plus (3+) years of experience in an FDA regulated environment with strong knowledge of regulatory compliance pertaining to software validation in IT Infrastructure and Enterprise Systems supporting business, manufacturing, or quality management (eg, Agile, SAP, MES) plus in-house developed software applications.
Three plus (3+) years' experience within a dedicated a CSV or product software validation role. Proficient in system and software validation engineering processes, software risk management, software V&V methodologies, and software configuration management.
Understanding of GAMP5 and risk-based approach to validation is required
Three plus (3+) years of experience in an FDA regulated environment with strong knowledge of regulatory compliance pertaining to software validation in IT Infrastructure and Enterprise Systems supporting business, manufacturing, or quality management (eg, Agile, SAP, MES) plus in-house developed software applications.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik, Organisation/Management