Beschreibung
Computer Systems Validation consultants
My Client is searching for Computer Systems Validation consultants.
The work will involve-
*Assuring that the Computerized Systems are tested and validated to satisfy regulations and addressing business and compliance needs
*Work with CSI professional to generate design documentation - functional specification and design specification
*Identify gaps in current design documentation and support the state of the installed control system
*May require execution of IQ's, OQ's, PQ's, FAT, SAT and other validation life cycle documents.
*Developing various test specifications which includes functional testing, system integration testing, performance testing and compliance testing
*Grow and maintain solid client relationships
To be considered for this position you must be able to demonstrate proven experience in the following -
*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.
*Knowledge within a dedicated 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
English speaking project environment.
Full details given upon application