SQL/PLSQL
Results-oriented Project Manager with extensive experience in leading digitization projects following SDLC processes. Proven expertise in managing GXP projects, conducting project governance, and ensuring timely delivery by overseeing stakeholders and risk management. Talented Project Lead with strengths in client management and problem-solving. Highly effective at managing multiple, concurrent projects.
SQL
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e-PQR Implementation
Product Quality Report (PQR) is requirement from regulatory agencies to have controlled system to monitor the product quality as well as OOS quality improvements for product by controlling critical product parameters.
PQR reports are manually prepared by collating the data from disparate sources to create annual quality report of the product.
Real-time data readily available for statistical evaluation and making quicker decision Detailed insights received in minutes for improving product robustness
Readily available data for regulatory submission, investigation and customer use. Effective and corrective action for QMS events.
Dashboard to avoid overdue of QMS events.
Medical Affairs Automation
The medical affairs personnel receive the cases from disparate sources and based on the four major criteria provided by International council of harmonization of technical requirements(ICH) guidelines the algorithm should classify the case as valid and Invalid and follow the separate workflow and prepare Individual case study report.
Monetary benefits for reducing executive headcount. Reduction in manual intervention – Time efficiency
Acts as repository for all the information as centralized system.
Product Launch Management System
The launch management application is intended to provide a platform for maintaining all the products to be launched with their market value, goal date and timelines for each milestone and respective stakeholders involved.
Replacing secluded spreadsheets Foresee risks
Timely notification
Timely planning for shortage of supply Visibility across the departments
Serialization Warehouse System
The Trace link system is used as series of code generator which is unique and non-repetitive. The business team are unable to identify the primary packaging and secondary packaging. The QR code generator implemented on the production lines helps the product tracking.
Audit requirement from USFDA to use QR codes Workforce efficiency and reduction.
Pharmacovigilance tracking system
The digital application to track the pharmacovigilance activities (PADER tracking, Follow-up tracker, Intake tracker, Case deletion tracker)
Audit control and visibility across the system
Overall equipment effectiveness
The application build on low code platform to track the equipment utilization to take timely actions.
Visibility across the Shop floor and minimization in errors
Dashboard Projects
SQL/PLSQL
Tableau
Visio