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Birendra Das
Birendra Das
Senior Executive in Quality Assurance
Birendra Das is a Senior Executive in Quality Assurance with over 8 years of experience in the pharmaceutical and biotechnology sectors, specializing in GxP compliance, microbiology, and quality systems implementation. He brings strong expertise in deviation and CAPA management, regulatory audit readiness, validation documentation, and data integrity in FDA, EMA, WHO, and MHRA-regulated environments. Skilled in QMS operations, change control, microbial testing, and validation of cleanroom and cell bank processes, Birendra ensures robust compliance and process sustainability. With hands-on experience using LIMS, TrackWise, and eVALGENESIS, he delivers consistent quality oversight across manufacturing and microbiology operations.
FORMERLY AT
Onesource Specialty Pharma Ltd
LOCATION
Banglore,India
AVAILABILITY
Full Time
Skills
Audit Management Systems
EM Documentation Tools
eVALGENESIS
GMP Documentation Systems
LIMS
Microbiology Testing Instruments
QMS Tools
Work Experience
Senior Executive – Quality Assurance
Onesource Specialty Pharma Ltd
Dec 2023 – 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
eVALGENESIS, QMS Tools, Audit Management Systems, GMP Documentation Systems
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
