Experience in GxP Proccesa with good understanding of GAMP guidance, cGMP and GxP, 21 CFR Part 210, 211 and 11, EU Annex 11 requirements & Involvement in Lab CS & Mfg System as per GAMP 5 strategy & V Model, and Infrastructure Qualification.IT Infrastructure Management: - Servers and Network Management, End user Infra Support, Inventory management for IT Hardware and Software’s. Backup-restoration, Archival-Retrieval of electronic data & security controls.Management of Quality Informatics, Management of Manufacturing Informatics, PLCs, SCADA & Computer System Validation and SDLC ProcessesProject Management for Local Quality and Manufacturing Projects and to Support Implementation of Global Projects. Monitoring, Execution & timely reporting for all the ongoing activities at sites. Including user training related to new SOPs, Policies, and Applications etc.