Responsible for implementing & maintaining Genpact PVAI Quality Management System (QMS).
Responsible for managing the compliance of Service Delivery Framework based out of ISO 20000 / ITIL
Provide QA and process expertise within development team and Quality Assurance.
Help the QA team in defining processes needed for the QMS
Coordinate & support internal and external audits
Accountable for ensuring there are NO / less non conformances during external audits.
Manage CAPA / Deviations to effective closure
Collect track key metrics / KPI to improve processes
Provide any process training or QMS trainings and maintain oversight on the training process
Support in implementing the QMS processes and agreeing on any tailoring for the release / project.
Ensures that development team are following the agreed process which meets both external and internal requirements
Conduct toll gate reviews
Collaborates with other stakeholders in Genpact to direct compliance issues to appropriate existing channels for investigation and resolution.
Help the QA to achieve targets based on the QA strategy, approach and execution in development projects.
Additional tasks as assigned by the Quality Lead
Graduate / Post Graduate
Experience in software quality and a minimum relevant experience in healthcare / pharma domain. Demonstrable working knowledge of GAMP 5 Guidelines, ISO 9001, FDA Part-
11 & ITIL / ISO 20000 standards and general financial, procurement, quality assurance, and human resource procedures
Electrical / Electronics / Computer Science Engineering