Pradipti Prakash

Serve as a key member of software development team as Solution Delivery Advisor on development projects for Pharmaceutical Companies.

• Worked with team in migration of legacy Chain of Identity/Chain of Custody system to SFDC for one of top 20 Pharmaceuticals.
• Worked with team in migration of legacy Slot Management system to SFDC for one of top 20 Pharmaceuticals.
• Trained on US Regulatory & Compliance 21 CFR part 11, EU GMP Annex 11, GAMP, Computer system validation (Q-CSV)/ (GXP) for ERP applications with Business Process integrations, GDP/ test Cycle Phase, Pre/ Post script review, Approval Process and V Model.
• Involved in Validation of User & Functional Requirements, Creation of Test Scripts, Execution of Test Scripts, Defect Management, OS Verification Testing, Language Verification Testing for different countries, Tracebiality Matrix, Change controls and helped the client in successful deployment of these applications in multiple countries.

Serve as a key member of software development team as Solution Delivery Associate on development projects for Pharmaceutical Companies. Work in a QA testing team in developing and implementing quality assurance and quality control methodologies. Ensure compliance with QA standards, federal regulations and customer specifications.

Results:

• Worked with team in migration of legacy ERP system to SAP for one of top 20 Pharmaceuticals.
• Trained on US Regulatory & Compliance 21 CFR part 11, GAMP, Computer system validation (Q-CSV)/ (GXP) for ERP applications with Business Process integrations, GDP/ test Cycle Phase, Pre/ Post script review, Approval Process and V Model.
• Involved in Validation of User & Functional Requirements, Creation of Test Scripts, Execution of Test Scripts, Defect Management, OS Verification Testing and Language Verification Testing for different countries and helped the client in successful deployment of these applications in multiple countries.
• Authored Validation Master Plans and Reports. Conducted Validation review of User, Functional and Regulatory Requirements. Reviewed Functional Risk Assessments, perform Design Reviews and code reviews. Prepared Traceability Matrix.
• Experienced in Project Quality Management: Adherence to CSV and Risk Management SOPs, System Life Cycle SOPs, Change Control Procedures, Operational Support/IT service Management policies/procedures.
• Worked closely with Business, IT and QA experts to identify IT/Process GAPs and introduce process/IT Improvements, Focused on GxP compliance and cost effectiveness.
• Served as JIRA SME and Tailored Waterfall / Agile (Scrum) methodologies to best fit business need by leveraging JIRA for implementation project, requirements gathering, test executions, traceability matrices and sprint burn downs, and applying appropriate stage-gate deliverables to ensure transition of project phases

• Authored and tested Validation Master Plans and Reports. Conducted Validation review of User, Functional and Regulatory Requirements. Reviewed Functional Risk Assessments, perform Design Reviews and code reviews. Prepared Traceability Matrix.
• Experienced in Project Quality Management: Adherence to CSV and Risk Management SOPs, System Life Cycle SOPs, Change Control Procedures, Operational Support/IT service Management policies/procedures.