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Gautam Prakash

QA Compliance Specialist | QMS | CAPA | Deviations | GMP Compliance | Pharmaceutical Quality Assurance

Bengaluru

3+ years of work experience

OneSource
Mar 20264 mosPresent

Bengaluru, Karnataka, India

Microbiology Compliance and Documentation including handling CAPA, Deviation and Change Control in Trackwise Software.
OneSource
Mar 20251 yr 1 moMar 2026

Bengaluru

Documents work in a clear and organized manner on the data sheets, following GDP. *Works under close supervision to ensure all work performed is executed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration. * Assisting with closure of CAPA's, OOL's in Production environment by following ICH Q9 Guidelines on Quality Management Principles at work site.
Steriscience
Aug 20231 yr 7 mosFeb 2025

Bengaluru, Karnataka, India

Education

Advanced Program in Clinical Research Management, Clinical Data management

clini india

20241 yr2025
Institute of Good Manufacturing Practices India (IGMPI)

Professional Certification, Pharmaceutical GMP

Institute of Good Manufacturing Practices India (IGMPI)

20231 yr2024

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Headline

QA Compliance Specialist | QMS | CAPA | Deviations | GMP Compliance | Pharmaceutical Quality Assurance

About

Quality Assurance professional with experience in pharmaceutical manufacturing, specializing in audit readiness, GMP compliance, and CAPA management. Currently working on audit response handling, deviation investigation, and continuous improvement initiatives (RISE Project). Skilled in GxP compliance, root cause analysis, and quality systems, with a strong interest in global regulatory standards and European pharmaceutical environments. Actively seeking opportunities in Quality Assurance and Compliance within international pharmaceutical organizations.

Location

Bengaluru

Work experience

Executive-Quality Assurance at OneSource, Mar 2026 - Present · 4 mos, Bengaluru, Karnataka, India, Microbiology Compliance and Documentation including handling CAPA, Deviation and Change Control in Trackwise Software.

Microbiologist Analytical Support at OneSource, Mar 2025 - Mar 2026 · 1 yr 1 mo, Bengaluru, Documents work in a clear and organized manner on the data sheets, following GDP. *Works under close supervision to ensure all work performed is executed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration. * Assisting with closure of CAPA's, OOL's in Production environment by following ICH Q9 Guidelines on Quality Management Principles at work site.

Trainee Microbiologist at Steriscience, Aug 2023 - Feb 2025 · 1 yr 7 mos, Bengaluru, Karnataka, India

Education

Advanced Program in Clinical Research Management, Clinical Data management, clini india

Professional Certification, Pharmaceutical GMP, Institute of Good Manufacturing Practices India (IGMPI)

Gautam Prakash - Executive-Quality Assurance in Bengaluru | Tal