Prabaharan Gurusamy

Senior Quality Assurance / Quality Control Leadership - Pharmaceutical Manufacturing

Talent

Flat No. 104, SRNR Daffodil, Ramanashree California Garden Layout, Yelahanka, Bengaluru, Karnataka, India-560064Member since July 24, 2026

cGMP ComplianceData IntegrityValidation and QualificationCAPA ManagementVendor QualificationRegulatory DocumentationAudit HandlingKFIR

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cGMP ComplianceData IntegrityValidation and QualificationCAPA ManagementVendor Qualification

About

With over 19 years of experience in API and pharmaceutical manufacturing environments, I have successfully led Quality Operations, Quality Systems, Validation, Compliance, and Regulatory Audit preparedness across reputed organizations including Mavion Pharmasciences (Formerly known as Sonia Organics), Flowchem Pharma, Vinta Laboratories, Lantech Pharmaceutical, R L Fine Chem, Syngene International Ltd., and Cipla Ltd. Throughout my career, I have developed strong expertise in cGMP compliance, Quality Management Systems, Data Integrity, Validation and Qualification activities, CAPA management, vendor qualification, regulatory documentation, and audit handling. I have actively supported and managed audits from regulatory authorities including USFDA, TGA, and KFDA, and contributed to successful regulatory outcomes including EIR closure activities.

Experience

Head quality - Mavion Pharmasciences (Formerly Sonia Organics) - Bengaluru, Karnataka

(2024-10)

Head of Quality (QA & QC)

Senior Manager - Flowchem Pharma Pvt. Ltd. - Hindupur, Andhra Pradesh

(2023-09 - 2024-07)

Head of Quality (QA & QC)

Played a key role in commissioning, qualification, and validation of new projects at Flowchem Pharma

Senior Manager - Vinta Laboratories Pvt. Ltd. (Formerly Swaasa Pharma Pvt. Ltd.) - Visakhapatnam, Andhra Pradesh

(2020-07 - 2023-09)

Head of Quality (QA & QC). Note: Joined Jul 2020 in Lantech Pharma and The Lantech Management sold the company and took over Swaasa pharma in the month of Dec-2021 and continued with same Lantech management since July 2020 to Sep 2023 (~3 years).