- To review software validation deliverables of centralized GxP software
- To review change controls, Deviation and CAPA of centralized GxP software
- To coordinate and conduct training programs and workshop (internal and external) on current cGMP trend, central quality policy, standard practice and directive as and when required.
- To review computerized systems documents with respect to established procedures and current regulatory requirements to assist site user for compliance
- To ensure shop floor IT compliances at sites such as compliance of IT Standard Operating Procedure, User Access Management, Data center Qualification and Network Qualification
- To perform onsite verification of Global CAPA/ Informatics/Quality Intelligence points for computerized system
- To Provide support to the sites for Regulatory Audit preparation
- To Provide resolution for queries related to computerized system
- To proactively identify emerging cGMP requirement with respect to computerized system and implementation as and when required.
- To perform gap assessment related to Computerized system with respect to regulatory guideline, US FDA 483 form, USFDA warning letter