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
21
21
years of professional experience
4
4
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
undefinedCertification
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
IT Quality and Compliance Lead
Biocon Biologics
12.2019 - Current
Manager-QA Engineering
Encube Ethicals
05.2018 - 12.2019
Manager-Engineering (Validation)
Emcure Pharmaceuticals Ltd
10.2004 - 04.2018
Bachelor of Engineering (B.E.) - Biotechnology
Visvesvaraya Technological University (VTU)
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