Amit Misra Email & Phone Number

Westfield, In, Us

Bonn, De

Communicate with cross functional leaders and align priority with stakeholders to improvise Greenfield plant, drive tech deliveries, manage dependencies, monitor progress. Tech solutions includes IT and robotics integrations, highly customized WMS. My responsibilities are:• Represent IT team in business and customer meetings.• Participate in design discussion, remove ambiguity from business requirements.• Team Management (Prioritization, cross-function training, technical leadership etc.), Vendor Management, Stakeholder Management, Knowledge Management etc.)• Actively participate in change control board meetings.• Work as though leader to manage Tech delivery by proactively identifying potential risk and build sustainable solutions.

Project 1: IoT engagement: Implemented IOT platform for multiple plants across the globe to get data from variety of GxP data sources in different levels (1/2/3/4) following S-95 architecture and make it available for data analytics, which has addressed data integrity challenges in these sources including disconnected equipment's. My responsibility includes understanding business need, creating implementation strategy involving stakeholders across GEO from different departments, closely work with network security teams, participate in architectural discussions and involve quality team to produce appropriate validation deliverables to fulfill regulatory requirements. Project 2: Data Integrity Anomalies: Anomaly Identification through periodic audit trail review is not sufficient as their early detection can avoid queries and improve the process itself. So implemented platform and solution for the same for various plants to find data integrity anomalies through visualization solution. Project 3: Automation: To improve compliance & response time, bring standardization and optimize operational cost, automated multiple use cases such as dynamic mapping across systems in case missing ontologies, business workflows automation, SOP based activities etc. Project 4: Cloud Migration and Development (AWS): Executed projects in AWS for re-hosting and refactoring the global application in pharma clinical domain to enable high availability, improve performance and loosely coupled integrations. Used EC2, PostgreSQL, SNS, SNS, S3, Direct Connect, DMS, RDS, ELB, SCT, Lambda, Cloud formation, Security groups etc. Project 5: Application Development (Salesforce): Gathered business requirement for building portfolio management application in R&D business area, executed project to build an application which can be accessed beyond customer firewall so that third party organizations can work with customer and massive data migration was also in scope.

Cloud Migration and Development (AWS): Executed projects in AWS for re-hosting and refactoring the global application in pharma clinical domain to enable high availability, improve performance and loosely coupled integrations. Used EC2, PostgreSQL, SNS, SNS, S3, Direct Connect, DMS, RDS, ELB, SCT, Lambda, Cloud formation, Security groups etc.Application Development (Salesforce): Gathered business requirement from R&D business groups, executed project to build an application which can be accessed beyond customer firewall so that third party organizations can work with customer and massive data migration was also in scope. Technologies used are force.com and node.js

Argus Safety: Executed projects which includes data migration into Argus , build custom reports (such as DSUR, PSUR etc.) for reporting to regulatory agencies. Managed Argus support projects which includes creating new/update reporting rules, solve day to day issues, doing periodic activities such as MedDra upgrade etc. Veeva RIM Data Migration: Customer moved away from COTS applications to Veeva RIM to improve processes, increase reusability but data migration was big challenge, Build strategy and architecture for data migration into Veeva RIM which includes data related to Product Registration, Submission, Labeling etc.Integration Projects: Solved burning challenges of data unavailability, data latency across systems by creating real time integration across SAP and COTS systems to avoid material waste, improve order fulfillment, drug dispensing in Clinical Supply Chain. Data sources were SAP IDOCS, XMLs, Enterprise Service Bus (FUSE), IBM MQ, databases etc. Informatica and API based architecture was used to build these integrations.Support and maintenance of data lake which use to get data from 14 discrete sources in batch mode and 65 consumers were getting data from the lake. Master data management: Build MDM for clinical data flow which includes sub domains like Study, Therapeutic Area, Site etc. using Informatica MDM.Datawarehouse/Datamart Designer: Designed data warehouse, Integrated data marts and batch integration for pharma manufacturing customer where data was getting ingested from more than ten applications which includes SAP, Trackwise, DeltaV, OSIPI, ASPEN, LIMS etc.