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Bhavna Reddy
Bhavna Reddy
Quality Assurance and Computerized System Validation (CSV)
Bhavana Reddy is a Quality Assurance and Computerized System Validation (CSV) professional with 12 years of experience in regulated pharmaceutical and biotechnology environments. She specializes in validation lifecycle management, risk-based validation, LIMS master data configuration, and implementation of GxP systems compliant with GMP, GAMP 5, 21 CFR Part 11, FDA, EMA, and ICH guidelines. Bhavana excels in managing quality systems, authoring validation documentation, and ensuring data integrity across critical systems. With strong cross-functional coordination and deep domain expertise in QMS, CAPA, and regulatory compliance, she delivers reliable, compliant, and business-aligned system validation solutions.
FORMERLY AT
One Source Speciality Pharma Ltd.
LOCATION
Banglore,India
AVAILABILITY
Full Time
Skills
Analytical Instruments
Chromeleon 7.2
CSV Documentation Systems
EDMS
ELMS
eVLMS
GAMP 5 Framework
LIMS
LIMS (Labware 7)
QMS Modules
Risk Assessment Tools
SAP
SAP (QM Module)
TrackWise
Validation Protocols (IQ/OQ/PQ)
Work Experience
Senior Executive – One Source Speciality Pharma Ltd.
One Source Speciality Pharma Ltd. (formerly Stelis Biopharma Ltd.)
Apr 2021 – Present
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Implemented and validated multiple GxP-regulated systems including LIMS, TrackWise, SAP, EDMS, and ELMS.
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Managed LIMS master data configuration, system integration, and data migration activities.
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Developed SOPs for LIMS data management and supported CSV lifecycle activities.
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Authored and reviewed validation documents aligned with GAMP and regulatory guidelines.
TECHNOLOGIES
LIMS (Labware 7), TrackWise, SAP (QM Module), EDMS, ELMS, eVLMS, CSV Documentation Systems, GAMP 5 Framework
Executive
Executive – Alembic Pharmaceuticals Ltd
Mar 2017 – Dec 2019
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Supported QMS and CSV processes across regulated systems.
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Conducted risk assessments, validation testing, and system documentation activities.
TECHNOLOGIES
TrackWise, QMS Modules, Validation Protocols (IQ/OQ/PQ), Risk Assessment Tools, EDMS
Quality Control Officer
Astral Steritech Ltd.
Mar 2016 – Mar 2017
Performed QC analysis and supported documentation and compliance activities in a regulated lab environment.
TECHNOLOGIES
Analytical Instruments, LIMS, SAP, Chromeleon 7.2
