Vishal Patil

IT Quality and Compliance ( Validation specialist)

Banglore

Summary

Seasoned IT Quality and Compliance Lead with over 10 years of experience in Computer System Validation (CSV) across manufacturing, laboratory, and enterprise applications in GxP-regulated environments. Proven expertise in implementing and validating systems such as TrackWise, Veeva Vault, MES, SAP Maintenance, eLog, EvLMS, and DMS, with a strong foundation in GAMP 5, 21 CFR Part 11, and EU Annex 11. Adept at leading cross-functional teams, managing global validation projects, and ensuring audit readiness. Known for a methodical approach, stakeholder alignment, and continuous improvement in IT quality processes.

Overview

years of professional experience

Certifications

Work History

IT Quality and Compliance Lead

Biocon Biologics

12.2019 - Current

Led CSV lifecycle for MES, TrackWise, Veeva Vault, SAP Maintenance, and EvLMS across multiple manufacturing and lab sites.
Directed a team of 8 validation specialists and coordinated with QA, IT, and business stakeholders.
Authored and reviewed validation deliverables including URS, FRS, Risk Assessments, IQ/OQ/PQ, and Traceability Matrix.
Ensured compliance with GxP, 21 CFR Part 11, and data integrity principles during system upgrades and new implementations.
Supported successful regulatory inspections by FDA and WHO with zero critical observations.
Implemented risk-based validation strategies and harmonized SOPs across global sites.
Spearheaded integration of MES with SAP and LIMS systems for streamlined data flow.
Self-motivated, with a strong sense of personal responsibility.
Excellent communication skills, both verbal and written.
Managed time efficiently in order to complete all tasks within deadlines.
Assisted with day-to-day operations, working efficiently and productively with all team members.

Manager-QA Engineering

Encube Ethicals

05.2018 - 12.2019

Led QA oversight for engineering compliance, equipment qualification, and computer system validation, ensuring regulatory alignment and audit readiness.
Reviewed and approved qualification documents (URS, DQ, IQ, OQ, PQ, RTM) for process equipment and clean utilities (HVAC, water systems, process gases).
Validated PLC and SCADA systems through comprehensive document review and approval.
Developed preventive maintenance procedures and reviewed PM/calibration schedules and records.
Investigated equipment breakdowns, analyzed trends, and implemented CAPAs for recurring failures.
Approved facility and HVAC drawings/layouts and addressed calibration failures through OOS investigations.
Authored compliance responses to regulatory findings related to facility and equipment.
Conducted internal audits and self-inspections across cross-functional departments to maintain audit readiness.
Managed change controls and deviations using TrackWise software for equipment, utilities, and facility modifications.
Prepared investigation and assessment reports for validation-related deviations.
Reviewed risk assessments, CAPA plans, and verified implementation of quality system actions.

Manager-Engineering (Validation)

Emcure Pharmaceuticals Ltd

10.2004 - 04.2018

Led equipment qualification, computer system validation, and engineering compliance across regulated environments.
Managed regulatory audits (US FDA, EMA, ANVISA, TGA, MCC) and ensured audit readiness through robust QMS oversight.
Qualified HVAC systems, cleanroom facilities (Grade A/B/C/D), pharmaceutical water systems, and pure steam units per ISO 14644 and EN-285 standards.
Conducted performance qualification for process gases (Argon, Nitrogen, Compressed Air) per ISO 8573 and executed smoke studies for aseptic airflow validation.
Performed temperature mapping/heat distribution studies (WHO TRS 961) and validated clean utilities and process equipment.
Authored and executed validation protocols for equipment, utilities, and computer systems.
Oversaw change management, deviations, and CAPA implementation within the quality management system.
Certified internal auditor and investigator for complex engineering and compliance issues.

Education

Bachelor of Engineering (B.E.) - Biotechnology

Visvesvaraya Technological University (VTU)

01.2012

Skills

QMS & Enterprise: TrackWise, Veeva Vault, DMS, EvLMS

Manufacturing: MES (Werum PAS-X, Rockwell), SAP Maintenance

Validation: Test Management Tools, Excel, Word, SharePoint

Integration: LIMS, SCADA, ERP Systems

Project & Team: JIRA, MS Project, Confluence, Teams

Certification

GAMP 5 & CSV Fundamentals – ISPE

Core Competencies

Computer System Validation (CSV)
GxP Compliance & Regulatory Standards
Quality Management Systems (TrackWise, Veeva Vault)
Manufacturing Execution Systems (MES – Werum PAS-X, Rockwell PharmaSuite)
SAP Maintenance Module Validation
Electronic Logbooks (eLog) & LMS (EvLMS)
Document Management Systems (DMS)
Validation Documentation (URS, FRS, IQ, OQ, PQ, TM)
Audit & Inspection Support (FDA, EMA, WHO)
Team Leadership & Stakeholder Engagement
Risk-Based Validation & Data Integrity
SOP Development & Process Optimization
Integration with ERP, LIMS, SCADA Systems

Timeline