Amit Bhaskar

Senior CSV & IT Quality Leader with 29 years of IT experience including 18+ years of Computer System Validation (CSV), Data Integrity and GxP Compliance across pharmaceutical, biotechnology, healthcare and life sciences organizations. Extensive expertise in end-to-end validation of enterprise applications including LIMS, QMS, SAP, DMS, CDS, SDMS and Manufacturing Systems following GAMP5, FDA 21 CFR Part 11, EU Annex 11, ALCOA++ and CSA principles. Strong experience authoring complete validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ Protocols, Traceability Matrix, Validation Summary Reports, Change Controls, Deviations and CAPA while partnering with QA, QC, IT, Engineering and Regulatory teams.

Recognized for driving global validation programs, regulatory inspection readiness, digital quality transformation and enterprise-wide IT compliance.

Validation Lead - Moderna TX Inc.

(2024-04)

• Lead validation activities for enterprise GxP applications including LabVantage LIMS, Chromeleon CDS, LogiLab SDMS and Veeva Vault QMS.
• Author Validation Plans, URS, Functional Specifications, Risk Assessments, IQ/OQ/PQ, Traceability Matrix and Validation Summary Reports.
• Support enterprise-wide Computer Software Assurance (CSA) implementation.
• Execute periodic review, change control and validation lifecycle management.
• Collaborate with Digital, QA, QC, Business and IT teams for validation activities.
• Maintain regulatory compliance with FDA 21 CFR Part 11, Annex 11 and GAMP5.

Head – Data Integrity & Computer System Validation - Teva Pharmaceuticals India Pvt. Ltd.

(2021-04 - 2024-01)

• Led CSV and Data Integrity programs across two manufacturing sites.
• Established enterprise CSV governance following GAMP5, FDA 21 CFR Part 11 and EU Annex 11.
• Authored and reviewed: Validation Plans, Vendor Assessments, Risk Assessments, IQ/OQ/PQ Protocols, Validation Summary Reports, Change Controls, Deviations, CAPA
• Performed Root Cause Analysis and remediation for validation issues.
• Developed SOPs covering Change Control, Backup/Restore, User Access Management, Disaster Recovery and System Retirement.
• Supported USFDA and MHRA inspections with zero critical observations related to CSV.
• Trained cross-functional QA, QC, IT and Engineering teams on CSV and Data Integrity.

General Manager – Software Validation - Lupin Limited

(2009-07 - 2020-11)

Directed enterprise Computer System Validation across 17 global manufacturing facilities.

• Managed validation strategy for: SAP, LIMS, QMS, DMS, LMS, CDS, SCADA, DAS, MES, Manufacturing Systems
• Led validation of SAP GMP modules including MM, QM, PP, PM and SD.
• Authored and approved Validation Plans, IQ/OQ/PQ, Validation Reports, Risk Assessments and Traceability Matrix.
• Managed validation lifecycle from implementation through retirement.
• Conducted Corporate CSV audits and Data Integrity assessments.
• Partnered with QA, QC, Manufacturing, Engineering, Site IT and external vendors.
• Supported multiple successful USFDA, MHRA, WHO, TGA and ANVISA inspections.
• Validated enterprise SAP implementation across manufacturing operations in record one-month timeline while maintaining full regulatory compliance.

Associate Consultant – Life Sciences - TCS

(2008 - 2009)

Senior Project Leader - ITC Infotech

(2007 - 2008)

Manager – Global Manufacturing - Ranbaxy Laboratories

(2006 - 2007)

Senior Consultant - Essar Information Technology

(1999 - 2006)

Software Engineer - Shell Information Technology Limited

(1998 - 1999)

Software Engineer - ANS Software Private Limited

(1996 - 1998)

Executive MBA - Senior Management - Indian Institute of Management Calcutta

Bachelor of Engineering - Computer Science