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Manohar Pujari
Manohar Pujari
Manager – Combination Product Quality Complaints
Dedicated Quality and Clinical Compliance professional with 13+ years of experience in the pharmaceutical and biologics sectors, specializing in Quality Assurance (QA), Quality Management Systems (QMS), and clinical/medical review of product complaints and investigations. Expertise spans across injectables, OSD, biologics, and medical devices, ensuring global regulatory compliance (USFDA, EMA, TGA, WHO, ANVISA). Skilled in CAPA management, deviation investigation, process validation, and data integrity (ALCOA+), with a strong background in clinical safety evaluation, audit readiness, and team leadership.
FORMERLY AT
Amgen
LOCATION
Banglore,India
AVAILABILITY
Full Time
Skills
Argus Safety
Caliber QMS
Empower
eTMF Systems
LIMS
Microsoft Power BI
MS Excel (complaint tracker)
SAP-QMS
TrackWise
TrackWise EQMS
Veeva Vault
Veeva Vault QMS
Work Experience
Manager – Combination Product Quality Complaints
Amgen
2022 – Present
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Lead medical and clinical review of global combination product complaints for accuracy and regulatory compliance.
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Collaborate with global safety and pharmacovigilance teams for complaint evaluation and clinical correlation.
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Conduct trend analysis and provide medical justification for complaint closures.
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Review and approve investigation summaries and CAPAs ensuring compliance with FDA/EMA standards.
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Interface with R&D, Manufacturing, and Regulatory Affairs for post-market safety and surveillance input.
TECHNOLOGIES
TrackWise EQMS, SAP-QMS, Veeva Vault QMS, Caliber QMS, Argus Safety, MS Excel (complaint tracker), Empower
Quality Operations & Compliance Lead
Laurus Global Formulations
Apr 2022 – Apr 2025
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Directed end-to-end QMS operations including complaints, deviations, OOS/OOT, and CAPA lifecycle management.
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Conducted clinical and medical reviews of complaints for injectables and biologics portfolios.
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Led recall management, risk assessments, and audit responses for USFDA, TGA, ANVISA, and WHO.
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Ensured pharmacovigilance-linked complaint processing and GxP compliance.
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Drove data integrity enhancements and improved inspection readiness metrics by 20%.
TECHNOLOGIES
SAP-QMS, TrackWise, Veeva Vault, Empower, LIMS, eTMF Systems, Microsoft Power BI
