BANDI VINEETHA

Results-driven Senior Associate – Software Validation with 3+ years of experience in computerized system validation (CSV), GxP compliance, and AI-enabled pharmaceutical quality systems. Skilled in implementing ValGenesis VLMS, Kneat Gx, Veeva Vault QMS, and MasterControl AI modules to streamline validation processes, enhance data integrity, and ensure compliance with FDA, EMA, and WHO regulations. Recognized for leading AI-driven validation initiatives that reduced audit risks, improved efficiency, and enabled digital transformation in pharma.

AI Tools & Digital Validation Expertise

• Document Review & Data Integrity – ChatGPT, Azure AI, Pinecone, Haystack: Auto-generate IQ/OQ/PQ protocols, perform risk assessments, smart SOP search, and ALCOA+ checks.
• Predictive Maintenance & Equipment Validation – IBM Watson IoT, SparkCognition, Uptake: Sensor data analysis, predictive failures, ensuring validated states.
• Process Validation (FDA Stage 1–3) – SIMCA, Seeq, JMP, Minitab, Spotfire: CPP-CQA modeling, DoE optimization, Continuous Process Verification.
• Computer System Validation (CSV/CSA) – ValGenesis VLMS, Kneat Gx, MasterControl VxT: Auto-generated test scripts, impact assessment automation, audit trail review.
• Quality Risk Management (ICH Q9) – RiskAI, Sparta TrackWise Digital, SAP QM: Risk scoring, CAPA trend analysis, critical control point identification.
• Regulatory Intelligence & Compliance Automation – Redica Systems, Montrium, PharmaReady: Scans FDA 483s/warning letters, maps regulatory risks to validation strategy.
• Automated Statistical Validation: Used JMP Pro for automated Linearity, LOD/LOQ, Precision, and Robustness analysis aligned with ICH Q2 guidelines.
• Regulatory Compliance (21 CFR Part 11 & QbD): Validated use of Empower with AI, ValGenesis VLMS, and SmartLab+ to detect audit trail gaps, ensure ALCOA+ compliance, and meet QbD/ICH guidelines.
• Real-World Pharma Applications: Applied AI models in HPLC Method Development, UV/VIS Spectroscopy, Dissolution Testing, and FTIR/NIR validation using chemometric PCA/PLS modeling.

• AI & Validation Platforms: ValGenesis VLMS, Kneat Gx, Veeva Vault QMS, MasterControl Validation, ComplianceQuest AI Modules
• Analytical Software: Empower-3, Agilent CDS OpenLab, LabSolutions, MassLynx, Chromeleon, Tiamo
• Process & Data Tools: SIMCA, Seeq, JMP Pro, Spotfire, KNIME
• Compliance Frameworks: GAMP 5, 21 CFR Part 11, EU Annex 11
• Automation & Integrity Tools: AI-driven QC Monitoring Systems, Predictive Analytics Engines, Electronic Validation Documentation Systems
• Analytical Validation Statistics (ICH Q2):Expertise in Linearity, Accuracy, Precision, LOD/LOQ, Robustness using JMP Pro regression, ANOVA, and DOE interaction plots

• Date of Birth: 11/08/1997
• Gender: Female
• Marital Status: Single

English, Hindi, Telugu, Pharma technology, AI tools, Yoga, Chess, Volunteering

• Gold Medalist – M.Sc. Chemistry, Kakatiya University (Top rank in class)
• 4× Outstanding Achievement Awards for validated systems with zero audit findings
• Led adoption of AI-enabled risk assessment tools, improving validation efficiency and documentation accuracy
• Streamlined digital validation records, reducing documentation time by 40%

• GAMP 5 – Good Automated Manufacturing Practice
• AI in Pharmaceutical Quality & Validation (Coursera)
• Computer System Validation (CSV) – Online Certification