Vijayalakshmi A

• Key Projects & Skills:

• Validation & Enterprise Applications Experience

• Micro Labs Ltd

• Projects / Systems Validated:

• Building Management System (BMS)

• Environmental Monitoring System (EMS)

• Manufacturing Tracking System (MTS)

• Caliber LIMS

• Air Handling Units (AHUs)

• E-Connect

• Key Skills:

• Computer System Validation (CSV) for GxP-regulated applications

• IQ/OQ/PQ Testing & Equipment Qualification

• ERP Validation, Risk-Based Validation, Periodic Review & Validation Assessments

• Compliance with GAMP 5 Guidelines, 21 CFR Part 11, FDA, MHRA, and TGA

• Audit Readiness, Change Control, and CAPA Implementation

• SOP Simplification and alignment with Waterfall Methodologies

• Adcock Ingram Ltd & Emmennar Pharma

• Projects / Systems Validated:

• Caliber LIMS Validation

• Static Data Creation

• Good Laboratory Practices (GLP)

• Key Skills:

• LIMS Qualification & Validation Lifecycle Documentation

• Static Data Configuration & Master Data Management

• GLP Compliance & Regulatory Documentation

• Digital Transformation-CSV

• Quality Assurance

Job Role

Hands-on experience in Computer System Validation (CSV) ensuring compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, and other regulatory standards

Skilled in GxP Risk Assessment, System Classification, and preparation of CSV deliverables including Validation Plans, URS/FRS, CDS, RTM, GxP Assessments, Validation Reports, and System Release Certificates

Acted as Audit Subject Matter Expert (SME), effectively explaining change management, risk assessments, and quality system applications for AHUs, Caliber LIMS, BMS, MTS, EMS, and other CDS systems

Expertise in conducting risk assessments to mitigate compliance gaps, ensuring adherence to FDA 21 CFR Part 11, EU Annex 11, and GxP guidelines

Successfully managed validation projects, ensuring on-time deliverables and providing weekly/monthly progress reports to leadership

Delivered validation of EMS, BMS, MTS, AHUs, and E-Connect, resulting in a 25% improvement in operational efficiency while maintaining full regulatory compliance

Proficient in LIMS master data creation and approvals for Raw Materials, Finished Products, and Packing Materials

Experienced in Chromatographic data management, including sequence template creation and review

Working knowledge of SAP, DMS, and Nichelon5 as an end user

Performed periodic audit trail verification in LIMS as a system owner, ensuring compliance and data integrity

Authored and reviewed Specifications, SOPs, and Raw Material/Excipient Harmonization in alignment with regulatory guidelines

Conducted software maintenance activities, including requirement gathering, issue reporting to vendors, and verification of system fixes

Prepared and executed test cases in validation and production environments as per the validation plan for LIMS qualification

Expert in handling Enterprise Applications, including SAP, LIMS, DMS, Nichelon5, BMS, EMS, MTS, and AHUs, with strong skills in validation, configuration, maintenance, and end-user support

Proficient in enterprise application lifecycle management — from requirement gathering, validation planning, and execution to periodic review, audit trail verification, and change management

Hands-on experience in system integration, data integrity, and compliance alignment for Enterprise Applications under 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines