Sneh Gandhi

• Led CSV execution for PLC, SCADA, and plant automation systems in pharmaceutical production, ensuring alignment with GAMP 5, 21 CFR Part 11, and EU Annex 11.
• Authored and reviewed validation deliverables including Software User Requirement Specification (URS), Software Qualification Plan (QP), System Impact Assessment (SIA), Software Configuration & Design Specifications (CS/SFDS), Software Functional Risk Assessment (FRA), Software Requirement Traceability Matrix (TM), Software Qualification Protocol & Reports (IQ/OQ/PQ), ITOT-Project Change Application (PCA), Deviation logs, and validation summary reports and Audit Trail Risk Assessment (ATRA).
• Conducted risk-based assessments to define test scope and controls for data integrity, security, and system functionality.
• Coordinated cross-functional reviews with Quality, IT, and Operations to ensure approvals, test evidence completeness, and inspection readiness.
• Supported commissioning and qualification activities for new equipment and upgrades, ensuring requirements coverage through traceability and executed test records.
• Managed vendors and integrators, reviewing automation deliverables and validation packs for compliance and consistency.

• Served as IT Compliance Lead for GxP automation systems, defining and verifying controls for access management, audit trails, backup restore, change control, and incident handling.
• Partnered with IT Security and Infrastructure teams to ensure OT systems met corporate standards while maintaining production uptime and GMP requirements.
• Supported internal external audits by preparing evidence, participating in walkthrough, and driving CAPA actions for observations.
• Established governance for lifecycle activities: periodic reviews, account recertification support, and validation maintenance planning.
• Assisted with computerized system SOPs and alignment of procedures with Part 11 Annex 11 expectations.
• Software Validation of eMBR & eLogbook applications for Manufacturing systems.

• IT Quality Assurance Management (Implementation of IT SOPs and Protocols)

• Test Planning and Execution in CSV of GxP software

• Compliance and Regulatory Requirements

• Collaboration with Cross-functional Teams

• Handling of Incident and Issue Management

• Handling Training and QMS activity related to IT

• Implementation of ValGenesis Application (eVLMS).

• Implementation of Centralization Application for Paperless User Management (eUAM).

• L1 Integration: Upgradation of Manufacturing Equipment as per 21 CFR Part 11 Requirements.

• MES Integration: Data Centralization of Manufacturing Equipment.

• Implementation Warehouse Management System through SAP.

• Data Acquisition system for IPQA Lab Instrument (Infinity Precise QMS).

• Support and Lead Software Validation Process for pharmaceutical process and packaging equipment using Rockwell Logix and Siemens S7 platforms.
• Support and maintained FactoryTalk View and WinCC HMI screens, alarm handling, interlocks, and operator workflows aligned with GMP practices.