Role Global Computer Validation Specialist Location Marlborough, MA Duties bull Hands on position responsible for validation of GAMP 5 Category 4 (configurable off the shelf) computer systems in a GxP environment. bull Authors all validation deliverables including risk assessments, validation plans, user requirements, test plans, test scripts, traceability matrix, test summary reports, and validation summary reports. bull Reviews executed test scripts. Provides input to the project manager for all validation activities and deliverables. bull Reviews vendor provided documentation for suitability. bull Participates in project team meetings with IT and Business. bull Requires participation in early morning andor evening teleconferences with global project teams. Skills bull Successful candidates will have strong validation experience including the validation of global data repositories (warehouse data lake) with analytics and collaboration tools in a GxP environment bull Have a good understanding of IT infrastructure terminology and concepts and a thorough understanding of electronic records and electronic signatures requirements (FDA, PICS, Annex 11). bull Must have excellent oral and written communication skills. bull Must be able to manage multiple validation projects at one time. bull Experience validating systems used to support clinical trials in a pharmaceutical environment (e.g. eTMF, CTMS, safety systems, clinical trial registration, statistical analysis, EDC) and GMPQMS activities (e.g. labeling artwork management, serialization, document management, learning management) preferred. bull Must have a minimum of 2 to 3 years' experience writing CSV test scripts, protocols and summary reports bull Bachelors or Masters in Computer Science, Computer Information Systems, Information Technology or related discipline.
Posting ID: 597001419Posted: 2021-02-25