Roles and Responsibilities
l Primarily focusing on project and operational routine support for Technical Software Application related to Pharma Regulatory and Pharmacovigilance.
Responsible for Applications like:-
RIMS (Regulatory Information Management System)
Drug Safety application : Oracle Argus,
Artwork Management System,
Learning Management System SABA .
l Work with Business Process Owners to ensure the business requirements implementation, Application uptime, Change request are meton time.
l Ensure user base is effectively trained and positioned to use all available system functionalities.
l Leverage existing applications, systems and processes for increase in utilization.
l Ensure IT activities are executed according to regulatory compliance standards. Work with Corporate QA to ensure compliance requirements are met.
l Manage the vendors / partners / support teams; coordinate with Lupin?s Subject Matter Experts (SMEs) and location IT team.
l 7 + years of experience in supporting Pharma software related to Regulatory and Pharmacovigilance area.
l Project Management & software Implementation experience.
l Ability to troubleshoot various application issues related to software programming, application & web server, database, hardware and network.
l Knowledge of Manufacturing, Quality and Regulatory processes in Pharma industry.
l Knowledge of GXP validated environment.
l Knowledge of software validation practices