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Priya Kumari

@priyakumari20

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I build microbiological quality and sterilization assurance for medical devices under GMP and ISO standards.

India

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What I'm looking for

I'm ready to relocate for a role in a European medical device or biotech organization where I can contribute microbiological quality control, sterility assurance, sterilization validation, and regulatory compliance expertise.

I'm currently establishing a BSL-2 microbiology laboratory at PharmaLab India Pvt Ltd aligned with EU GMP standards, while performing sterility, bioburden, and BET testing for medical devices.

Previously at Advance Medtech Solutions, I led a team of eight and closed microbiological compliance gaps that delivered ₹2 crore in cost savings. I executed EO, steam, chemical, and gamma sterilization validations and supported audits, CAPA, deviation investigations, and risk management.

Across Mais India Medical and Polymedicure, I've supported device release, environmental monitoring, water and disinfectant validation, regulatory inspections, and staff training. I'm ready to relocate and contribute to a European medical device or biotech organization.

Experience

Work history, roles, and key accomplishments

Current

Microbiologist

Current

Pharmalab India Pvt Ltd

Apr 2025 - Present (1 year 5 months)

Established a BSL-2 microbiology laboratory aligned with EU GMP standards. Conducted sterility, bioburden, and BET testing of medical devices and supported sterilization validation studies.

ISO 13485 ISO 22441 EN 285 Sterility Testing Bioburden Testing BET Endotoxin Testing Sterilization Process Validations Quantitative Microbial Risk Assessment (QMRA)CDSCO Documentation Steam Sterilization Validation

Executive Assistant

Advance Medtech Solutions

May 2023 - Apr 2025 (1 year 11 months)

Led a team of 8, achieving cost savings of ₹2 crore by closing microbiological gaps as per regulatory compliance. Executed EO, steam, chemical, and gamma sterilization validation studies and supported ISO audits and CAPA implementation.

EO Moist Heat Sterilization Gamma Sterilization Cleanroom and Micro Contamination Monitoring Disinfectant Validation Calibration Risk Management ISO 11737 ISO 11137 ISO 11135 ISO 11138 USP GMP CAPA SOP Development Training

Microbiologist

Mais India Medical Pvt Ltd

Dec 2022 - May 2023 (5 months)

Performed sterility, BET, and bioburden testing of medical devices. Conducted water testing, microbial limit testing, and environmental monitoring, and prepared COAs and release orders.

USP 43 Sterility Testing BET Endotoxin Testing Bioburden Testing Microbial Culturing Water testing Microbial Limit Testing Environmental Monitoring COA Preparation GLP 7QC Tools 6S 管理 5S+

Microbiologist

Polymedicure Ltd

Jul 2020 - Dec 2022 (2 years 5 months)

Conducted sterility, bioburden, and microbial monitoring activities. Performed WFI water validation and disinfectant validation, and supported ISO audits and regulatory inspections.