DEVARSHIKUMAR U. THAKER
Summary
- Experienced and detail-oriented QC Microbiologist with over 4 years of hands-on experience in the injectable pharmaceutical industry.
- Skilled in Water testing, Media Preparation, Testing of Biological indicators, and aseptic techniques under GMP-compliant environments. Proven ability to ensure microbiological quality and regulatory compliance across all stages of sterile product manufacturing.
- SME of Water testing for WHO and the Egyptian Drug Authority (EDA) Audits. Experienced in executing a supportive study protocol. Adept at managing documentation, audits, and cross-functional collaboration to support quality systems and product release.
Overview
4
4
years of professional experience
Work History
Officer -QC MICROBIOLOGY
Zydus Lifesciences, Ahmedabad
08.2023 - Current
- Bioburden Testing: Conduct bioburden analysis of raw materials, in-process samples, and finished injectable products as per validated procedures.
- Environmental Monitoring: Record and interpret data using Scan 4000 for microbial plate observations.
- Water System Monitoring & Qualification: Plan and perform Water System Performance Qualification (PQ) activities.
- Prepare and maintain monthly, quarterly, and annual summary reports of water analysis.
- Handle schedule preparation for daily/weekly/monthly water sampling and testing.
- Prepare Kit for Visual Qualification and conduct Qualification of Visual operator.
- Media Preparation & GPT: Prepare microbiological media and conduct Growth Promotion Testing (GPT) for validation and quality checks.
- Documentation & Compliance: Maintain test records, EM logs, trend charts, and ensure compliance with GMP, GLP, and ALCOA+ principles. Support internal and external audits.
- Instrument Handling: Operate and maintain key lab instruments such as autoclaves, incubators, LAF, isolators, particle counters, and Scan 4000 for colony count analysis.
- Regulatory Readiness: Support readiness and documentation for regulatory audits (WHO, CDSCO, EDA).
Trainee Officer – QC Microbiology
Zydus Lifesciences, Ahmedabad
08.2022 - 08.2023
- Conducted bioburden testing of raw materials, in-process, and finished injectable product.
- Performed environmental monitoring (EM) of sterile areas, including air, surface, and personnel monitoring in aseptic zones (Grade A/B/C/D).
- Operated manual colony counter for observation and documentation of microbial colonies on EM plates.
- Supported media preparation and conducted Growth Promotion Testing (GPT) of media used in QC.
- Assisted in OOS and MDD investigations, documentation, and implementation of CAPAs.
- Executed sampling and testing of WFI, Purified water, and pretreatment water.
- Maintained GMP-compliant documentation, logbooks, and test records.
Apprentice – QC Microbiology
Zydus Lifesciences, Ahmedabad
07.2021 - 08.2022
- Gained hands-on training in basic microbiological techniques used in sterile pharmaceutical environments.
- Perform water sampling and basic microbiological testing, and prepare the Monthly and Quarterly Trend report of water analysis.
- Supported the QC team in media preparation, autoclaving, and sterility room operations.
- Maintained sample logs, laboratory cleanliness, and helped with instrument calibration and routine documentation.
- Learned GMP guidelines, cleanroom gowning procedures, and aseptic techniques essential to QC microbiology.
Education
Master Of Science - Microbiology
CHARUSAT UNIVERSITY
Changa, Gujarat06.2021
Skills
- Water System Testing (WFI, Purified Water, and Pre-treatment water)
- Bioburden & Microbial Limit Testing
- Growth Promotion & Media Preparation
- Testing for Biological Indicator
- Equipment Handling: Autoclaves, Incubators, Particle Counters, LAF, SCAN-4000
- Environmental Monitoring (Viable and Non-Viable)
- GMP Documentation
- Report writing
- Work coordination
- Strategic planning
- Innovation and creativity
- Task prioritization
- Teamwork
Timeline
Officer -QC MICROBIOLOGY
Zydus Lifesciences, Ahmedabad
08.2023 - Current
Trainee Officer – QC Microbiology
Zydus Lifesciences, Ahmedabad
08.2022 - 08.2023
Apprentice – QC Microbiology
Zydus Lifesciences, Ahmedabad
07.2021 - 08.2022
Master Of Science - Microbiology
CHARUSAT UNIVERSITY
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