Devinder Kumar Email & Phone Number

Gurugram, Hr, In

Cloud Migration (Validation),Develop and Implement Cloud Migration Validation Strategy,Collaborate with Cross-functional Teams,Ensure GxP Compliance and Regulatory Adherence,Develop and Review Validation Documentation,Perform Data Integrity Risk Assessments (DIRA),Manage/Review Change Control, Incident and Risk Assessments,Lead Validation-related Audits and Inspections.

India

Leading GxP IT operations for Fresenius Kabi- India Region

India

Baddi, Himachal Pradesh

Gurgaon-Corporate Office (South East Asia) & Healthcare Mfg. Baddi (Usfda,Mhra)

Aug-2013 to Oct-2014Leading functional delivery helpdesk for JDEdwards and Distributor Management System helpdesk (Providing support to India, Bangladesh and Sri Lanka users). ERP:- JDEdwards, Applications:- Stocky (Zoom), SQL Server 2005, .net Achievements:-Successfully Lead and implemented Project tango (Cegedim) – Detailing solution for Pharma team at all India Level. Worked with Cegedim (France & India team for implementation) Successfully Lead and implemented RBSM (Spend Management) for all functions and regional offices across India. Centralized Online system to capture requisitions approvals, Purchase order, receipts, vendor Management and payment tracking.RECKITT BENCKISER HEALTHCARE INDIA LTD.LOCATION - BADDIMHRA, USFDA approved Plant.Apr-2007 to Jul-2013Managing hardware/network/application support.Server, Desktop, Laptop, Network switches, Routers, MPLS links, Video Conferencing equipments, Projectors, UPS, PRI’s etc L1 Point of contact for SAP concerns, coordinating with Accenture (SAP support team) and Functions for resolving queries. Ensuring SOD (Segregation of duties) are met. Handling facilitation of Computer System Validation programs across site. Responsible for ensuring IS infrastructure (GxP System, Applications) remains in validated state as per FDA, GAMP, EU GMP regulations including 21 CFR Part 11 and annex 11 requirements.Leading site CVT (computer validation team) committee. Planning, organizing and managing CVT meetings. Responsible for maintaining site IT inventory. Proposing and finalizing annual budget for site. Maintaining validated state of Server room and ensuring Backup and restore process is working smoothly. Authoring/reviewing/approving CSV, IT SOPs/validation documents developed by functional/validation, coordinating with vendors of all projects to check the status of project, carry out and review IQ, OQ, PQ scripts and protocols, results and reports.

Baddi

 Responsible for complete ERP operations for site involving Material management, Quality control, Production planning, material dispatch, Financial Accounting etc E.R.P. Package: - ALFIE PHARMA ERP FRONT END: - Visual Basic BACK END: - MS Access Coordinating with Business and providing support related with ERP.  Maintaining IT records ( System inventory)Achievements:- Worked with Soham computers, Gujarat in transition for ERP package from ALFIE Pharma ERP to MMS (Material management System)