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Harsh Kanojia
Harsh Kanojia
Validation & Compliance Lead
Harsh Kanojia is a Validation & Compliance Lead with 11 years of experience in Computerized System Validation (CSV) across global pharmaceutical and life sciences organizations including Novartis, GSK, Johnson & Johnson, Sanofi, Zoetis, and Purdue Pharma. He specializes in GxP system validation, SDLC management, GAMP 5 methodologies, testing, documentation, and regulatory compliance aligned with US FDA, EMA, 21 CFR Part 11, and Annex 11 guidelines. Harsh has extensive hands-on expertise with validation deliverables, risk assessments, test management, change control, audit trail reviews, and GRC tools. He excels in leading validation projects, managing quality operations, and ensuring end-to-end compliance across IT and manufacturing systems.
FORMERLY AT
Cognizant Ltd.
LOCATION
Bengaluru, India
AVAILABILITY
Full Time
Skills
Audit Management Systems
EM Documentation Tools
EMPQ Tools
eVALGENESIS
GMP Documentation System
LABWARE LIMS
LIMS
Microbiology Testing Instruments
NOVA LIMS
QMS Tools
TrackWise
Validation Protocol Systems
Work Experience
Operational Quality Manager
Cognizant Ltd.
May 2022 – Present
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Ensures compliance with FDA, EMA, and other regulatory agencies across microbiology and manufacturing operations.
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Conducts internal audits, quality risk assessments, and QRM reviews.
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Drafts and approves validation documents using eVALGENESIS.
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Performs root cause analysis for deviations, OOS, and OOL cases.
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Manages CAPA effectiveness, microbiology data review, and audit readiness.
TECHNOLOGIES
eVALGENESIS, QMS Tools, Audit Management Systems, GMP Documentation Systems
Senior Executive – Quality Control
Biocon Biologics
Sep 2020 – Dec 2023
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Led QMS activities including deviations, CAPA, change control, and failure investigations.
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Conducted OOS, OOT, and deviation investigations using TrackWise.
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Authored SOPs, specifications, and EMPQ protocols for cleanrooms.
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Performed validation for cell banks (Human Insulin, Insulin Glargine, PEG-GCSF).
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Ensured regulatory compliance (cGMP, cGLP, cGDP) and audit readiness.
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Implemented and optimized LIMS (LABWARE, NOVA, TrackWise) for QC workflows.
TECHNOLOGIES
LABWARE LIMS, NOVA LIMS, TrackWise, EMPQ Tools, Validation Protocol Systems
Quality Control Officer
Emcure Pharmaceuticals Ltd
Oct 2017 – Sep 2020
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Conducted microbiological testing (microbial limits, water analysis, GPT).
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Managed environmental monitoring and documentation for classified areas.
TECHNOLOGIES
Microbiology Testing Instruments, LIMS, EM Documentation Tools
