Amit Dekate
@amitdekate
Senior validation and compliance consultant delivering GxP-compliant CSV/CSA and Veeva Vault solutions for global pharma.
IndiaWhat I'm looking for
I’m a validation and compliance consultant with 15+ years across CSV, CSA, GxP quality systems, and enterprise software validation for global pharma and life sciences clients. I focus on practical, audit-ready delivery across the full validation lifecycle—from URS through IQ/OQ/PQ, traceability, and validation reporting.
I’ve delivered GAMP 5 Category 4/5 validation for MES (Werum PAS-X), LIMS, EDMS, SAP S/4HANA, Veeva Vault QualityDocs, and Clinical Trials Management Systems (CTMS), including Early Access Program (EAP) compliance under 21 CFR Part 312 and ICH E6 (GCP). I also led migration of 2,000+ controlled documents and supported audit readiness for US FDA and UK-MHRA inspections.
In senior advisory and project-quality roles, I’ve owned risk-based validation and change management for complex, regulated environments. I’ve served as Quality Manager/Test Release authority for clinical trial systems, led test management and defect governance, and authored strategies, RFP responses, and compliance-aligned cutover plans.
I’m IRCA/RABQSA Lead Quality Auditor and ISO 27001:2015 Lead Auditor, and I aim to bring end-to-end compliance ownership to teams needing strong GxP rigor and Veeva consulting expertise. I enjoy applying emerging themes like AI/GenAI in Veeva Vault, while keeping validation, data integrity, and documentation fully defensible.
Experience
Work history, roles, and key accomplishments
Advisor, Life Sciences
Tenthpin Management Consultants Pvt. Ltd.
Nov 2023 - Apr 2025 (1 year 5 months)
Led software validation across multiple SAP S/4HANA programs, managing staffing, budgets, resources, and risk for assigned streams. Served as Quality Manager and Test Release authority for an Intelligent Clinical Management System supporting EU global EAP trial operations, overseeing GxP test execution and release sign-off compliant with 21 CFR Part 312 and ICH E6 (GCP).
Led risk-based GxP and non-GxP project validation and change management for a US medical device multinational, applying the GAMP lifecycle. Acted as Validation Testing Lead for a CTMS supporting EAP activities and validated SAP–MES integration, RFID-based quality tracking, and an Informatica upgrade.
Authored validation strategies for enterprise GxP applications including EDMS, SABA, CTMS (eCOA), eLog, LIMS, QAMS, and RPA using GxP and risk-based assessment outputs. Led Veeva Vault QualityDocs implementation as an EDMS replacement and authored a migration strategy and data-mapping matrix to migrate 2,000+ controlled documents, supporting GAMP 5 Category 4 validation and 21 CFR Part 11 / EU Ann
Senior CSV Consultant
Swiss Datalynx (I) IT Solutions Pvt. Ltd.
Jan 2017 - Feb 2018 (1 year 1 month)
Led validation as Project Quality Manager for the Werum PAS-X 3.1.7 MES implementation across warehouse, manufacturing, and packaging processes. Designed the MES validation strategy and delivered VMP, risk assessment, ERES, and validation reports, supporting US FDA and UK-MHRA site audits for Sandoz.
Project Consultant, Quality
Artech Info Systems Pvt. Ltd.
Sep 2016 - Dec 2016 (3 months)
Reviewed migration of GxP applications against GAMP perspective, focusing on validation deliverables and release processes. Assessed test protocols, UAT activities, and change management compliance to GAMP 5, 21 CFR Part 11, and EU Annex 11.
Computer System Validation
Independent Freelance Consultant
Aug 2015 - Sep 2016 (1 year 1 month)
Defined a CSV strategy for SAP LIMS modules and the LIMS–EBMR integration framework. Authored validation plans and protocols (IQ/OQ/PQ, SDLC, QRM) aligned to 21 CFR Part 11, EU Annex 11, and GAMP 5, and completed vendor assessments and mitigation plans for LIMS, CTMS, and LMS.
Lead, CSV Modeling
Covacsis Technologies Pvt. Ltd.
Sep 2014 - Aug 2015 (11 months)
Led validation for an IoT-based life sciences application, including risk mitigation and the LIMS–EBMR integration validation approach. Authored IQ/OQ/PQ and QRM documentation per 21 CFR Part 11, EU Annex 11, and GAMP 5, and performed risk assessment, GAP analysis, and CAPA closure for Category 4 & 5 software.
Assistant Manager, QA & CSV
RPG Life Sciences Ltd.
Jun 2012 - Sep 2014 (2 years 3 months)
Implemented IT regulatory compliance and computer system validation for SAP QM/MM, SCADA (Allen-Bradley), and DCS (Emerson), aligned to 21 CFR Part 11, EU Annex 11, and GAMP 5. Conducted internal and vendor audits, supported regulatory/customer audits, managed market complaints and CAPA, and maintained the validation master plan, site master file, and SOPs.
Education
Degrees, certifications, and relevant coursework
National Institute of Management
Master of Business Administration, Marketing & International Business
Earned an MBA in Marketing & International Business from National Institute of Management in 2011.
University of Mumbai
Master of Science, Organic Chemistry
Earned an M.Sc. in Organic Chemistry from the University of Mumbai in 2004.
University of Mumbai
Bachelor of Science, Chemistry
Earned a B.Sc. in Chemistry from the University of Mumbai in 2002.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Job categories
Skills
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