Hire Vinay

Vinay Pillai

Quality Assurance Manager

Vinay Pillai is a Quality Assurance Manager with over 11 years of experience in Computer System Validation (CSV), eCompliance, and GxP-regulated systems across the pharmaceutical and biotechnology industries. He specializes in validation lifecycle management, regulatory inspection readiness, quality oversight, and compliance for enterprise and manufacturing systems. Vinay has deep expertise in 21 CFR Part 11, GAMP 5, CSV strategy, change control, CAPA management, and cross-functional collaboration with QA, IT, and business teams. With extensive hands-on exposure to Veeva, ServiceNow, LIMS, EDMS, SAP, DeltaV PCS, MES, OSI PI, and multiple validation/testing platforms, he consistently ensures regulatory alignment and drives continuous quality improvement across global operations.

FORMERLY AT

Moderna

LOCATION

Hydrabad India

AVAILABILITY

Full Time

Skills

DeltaV

DeltaV PCS

EDMS

HPQC

Infobatch

Kneat

LIMS

MES

OSI PI

SAP

SCADA

ServiceNow

Simca

SpiraTest

Statistica

+3 More

Work Experience

Manager – Computer System Validation,

Moderna

May 2021 – Present

Provides QA oversight for validation deliverables ensuring compliance with 21 CFR Part 11 and Annex 11.
Supervises CSV team supporting validation across GxP systems.
Reviews and approves URS, FRS, IQ/OQ/PQ, risk assessments, test scripts, and VSRs.
Supports regulatory inspections and leads quality event (deviation, change control, CAPA) governance.

TECHNOLOGIES

Veeva, ServiceNow, LIMS, EDMS, SAP, DeltaV PCS, MES, OSI PI, SCADA, Infobatch, TrackWise, Kneat, HPQC, SpiraTest

Validation Specialist

Takeda Pharmaceuticals,

Apr 2019 – Apr 2021

Led validation of automation/control systems including DeltaV, OSI PI, Statistica, and Simca.
Authored VMPs, risk assessments, SOPs, traceability matrices, and validation documents.
Participated in design reviews, tech transfers, and inspection preparation.

TECHNOLOGIES

DeltaV, OSI PI, Statistica, Simca, SAP, EDMS, Validation Documentation Tools

Technical Assurance Analyst

Merck

Jul 2018 – Mar 2019

Managed software qualification and CRQ workflows for Windows 10 Lab IT migration.
Conducted UAT, impact analysis, and documentation review for GxP applications.

TECHNOLOGIES

ServiceNow, HPQC, EDMS, Windows 10 Migration Tools