ESWARA PRASAD P

Joined Leica Biosystems, IT global application team as a senior business analyst, responsible for the implementation EQMS application (IQVIA smart solve) across various sites and simultaneously decommissioning of the existing TrackWise application. My key responsibilities include

• Work alongside QMS Subject Matter Experts (SME’s), and other business analysts to gather user requirements based on their use of the system, develop process maps, UAT Test scripts for critical quality processes
• Bridge the gap between business requirements, vendor specifications and the validation documents
• Authoring test scripts based on the LBS SOPs/work instructions and perfrom peer review of key validation documents (IQ and OQ scripts from IT Vendors), write PQ scripts and support validation lead with the computer system validation deliverables
• Support reviewing of the vendor software upgrade release notes, review design inputs and write testing scenarios.

Joined Navitas Life Sciences as a business analyst responsible for the implementation of TrackWise application for wide range of customers with adherence to current norms and regulations. My key responsibilities include

• Product Demonstration with stakeholders to identify the requirements and recommend solutions to address business needs complying to operations
• Conduct workshops, deduce business scenarios as per the client’s requirements and assist in the implementation and management of system enhancements
• Authoring the functional requirement specification documents, requirement traceability matrix, performing impact assessment and testing to ensure that the application meets clients’ specifications and requirements
• Translating Business requirements into technical user stories for development teams
• Qualify Release for customers deliverables and conduct mock demos at customer site effectively
• Demonstrate the completed configuration to the customer and provide technical assistance and knowledge transfer to end user user’s
• Assist with implementation and management of system enhancements and upgrades within a change control environment and performing Functional Risk Assessment for the functional requirements as part of change control management
• Active participation in the management of multiple projects at a time, ranging in complexity and size.

Joined Hospira as a manufacturing quality assurance executive, responsible for handling the quality attributes in warehouse and played a key role in achieving targets, handling regulatory and customer audits

• Later was recognized and promoted to the shop floor for taking care of the critical manufacturing, packaging, QMS activities, batch release and quality approvals
• During my tenure I was responsible for the following
• Provide guidance and plan of action to the manufacturing floor when production events occur, as defined by SOP
• Support in the investigation of exception reports (ER), quality assurance reports (QAR) and writing technical investigation reports (gQTS)
• Facilitating the review, implementation of the corrective and preventive actions (CAPA) commitments and monitoring of the effectiveness checks
• Reviewing the customer queries for completeness and accuracy and assisting the market complaints team in the investigations
• Imparting training to the manufacturing/packaging, quality assurance personnel and new recruits.