Priyanka Mathiyazhagan

Client: Alexion Pharmaceuticals

• I contracted as a Lab system Manager within Alexion IT, acting as a bridge between IT and QC and Point of Contact, helping to enhance and maintain GxP QC systems (e.g. gLIMS, Empower, NuGenesis SDMS, JMP).
• Led upgrade of empower software acting as a technical SME and IT Delivery manager.
• Acted as a SPOC and IT lead for multiple application.
• My role and responsibilities include: Stakeholder Management, Research and gap analysis, documenting, testing ,enhancement and change management.
• Client: Alexion Pharmaceuticals

• Labware LIMS Business Analyst, responsible for projects deployments deliverables aspects from defining user requirements, through implementing IT business solutions and testing activities.
• Provides technical support to Lab users and business groups through the use of troubleshooting procedures and testing.
• Leads projects following the PMO processes. Leads user acceptance testing and uses comparative analysis techniques to evaluate and recommend overall solutions for client.
• Helps to formulate and define system scope and objectives based on user needs and research and industry requirements.
• Provides consulting services to internal business groups on process improvements projects .

• Implementation of LIMS on different manufacturing facilities and providing technical support L2 and L3 to customers and business groups.
• Troubleshooting of technical issues with labware LIMS and ELN and deliver timely solutions to customer.
• Co-ordinate with business and understand requirements for frequently occurring issues and fix them.
• Configured and developed various static and dynamic data workflows based of customer requirements.
• To develop and configure LIMS templates according to customer needs and work with labware vendor for developing subroutines accordingly.
• Perform UAT testing, smoke testing and performance testing for newly developed projects.
• Co-ordinate with other infrastructure teams in case of any update or outage.
• Troubleshoot incidents reported by end-users to schedule system changes and identify permanent solutions.

Client: Takeda Pharmaceuticals

• Worked as manufacturing IT core member and handled support team management for multiple GXP applications.
• Performed internal system acceptance to deliver well-tested enhancements and meet business requirements and deadlines.
• Communicate business requirements to team members to understand and implement functional demands.
• Oversaw document development across project work streams to create internal control statements per compliance and regulatory standards.
• Management of LIMS background server Connect Install/ New printers for LIMS.
• Installation and configuration of instruments and monitor data transfer between systems.
• Analyze existing systems and databases and recommended enhancements, change requests to solve business needs.
• Prepare daily, weekly and monthly reports to present on status call and client meeting.
• Monitoring of background jobs and failure, server patching activity for LIMS and daily check list.
• Client: Takeda Pharmaceuticals

Client: Shire Pharmaceuticals

• LIMS Technical and functional consultant for 8 instances across globe to provide quick resolution to end users, hot Defect fixes and support by reproducing all type of issues and resolve within SLAs.
• Involved in Daily health checks to verify application performance, handling all types' printer issue from print server (Zebra, HP) and Network/Server related issues.
• Involved in report installation and handling major incident.
• Handling entire RNCD system which comprised of 8 nonclinical and clinical application like ELN, Dotmatics.
• Involved in application releases, application upgrade, migration and DR plans.
• Create/update documentation where applicable and maintaining it in SharePoint and Veeva vault.
• Handle all Weekly and Monthly Planed Outages.
• Enhance project management skills by defining and presenting system solutions and timelines for business needs or technical problems.
• Client: Shire Pharmaceuticals