Sakshi Sharma

Microbiologist/QA professional with 8 years of experience in pharmaceutical and medical device industries, including Class IIa & IIb medical devices and OSD, sterile, and non-sterile manufacturing plants. Skilled in sterility testing, microbial limit testing, bioburden, environmental monitoring, validation, GMP, and QA documentation. Experienced in compliance and audit support for CDSCO, DNV, BIS, EU MDR, ISO 13485, MDSAP, WHO, NABL, and Saudi FDA, with strong knowledge of microbiology and quality systems.

Senior Microbiologist - Paramount Surgimed Ltd - RIICO Industrial Area Bhiwadi Rajasthan

(2025-06)

Senior Microbiologist - Auxin Medical PVT. LTD. - Kundi, Sonipat, Haryana

(2023-01 - 2025-03)

• Perform sterility testing of sterilized orthopedic products.
• Conduct bioburden testing and Bacterial Endotoxin Testing (BET) of finished products.
• Manage media preparation, consumption tracking, and stock maintenance.
• Oversee calibration of laboratory instruments such as pH meters, heating blocks, and colony counters.
• Conduct culture suspension preparation, culture maintenance, and preservation.
• Lead accelerated and long-term stability studies for orthopedic implants.
• Prepare and maintain SOPs, protocols, and microbiological documentation.
• Conduct validations including autoclave validation, bioburden validation, and media hold-time studies.
• Perform routine temperature monitoring of BOD incubators, refrigerators, and stability chambers.
• Manage disinfectant preparation and effectiveness monitoring for laboratory operations.
• Support and conduct dose audits activities to verify sterilization process effectiveness and compliance.
• Lead steam sterilization and gamma sterilization validation and verification studies for orthopedic implants and medical devices.
• Perform dose audit to ensure effective and validated sterilization processes.
• Develop and implement test plans, protocols, and procedures for sterility, bioburden, and bacterial endotoxin testing.
• Conduct product testing, analyze results, and prepare technical documentation for audits and internal reviews.
• Oversee IQ, OQ, and PQ of laboratory instruments and ensure compliance with applicable regulatory requirements.
• Monitor environmental conditions, including temperature mapping of critical laboratory equipment.
• Provide technical leadership in sterilization validation and microbiological processes, ensuring regulatory compliance and GMP best practices.

Senior Microbiologist - Medi force Research Pvt. Ltd (Group of Mankind Pharma. Ltd.) - Himachal Pradesh

(2021-10 - 2022-08)

• Media preparation, media sterilization, disposal of media.
• Media consumption, issuance, stock maintenance
• Microbial Limit Test of Raw materials finished product by Filtration Method & Pour Plate Method.
• Pathogen Testing.
• Microbial Limit Test of purified water and water for injection and raw water.
• Growth Promotion, inhibition test of media.
• Environmental monitoring by Settle plate, Contact Plate Finger dabbing.
• Culture, Subculture, Culture storage.
• Culture maintenance, Culture preservation and preparation of master culture monthly culture and weekly culture from mother culture, Preparation of culture suspension
• Staining methods Gram 'stain, Acid fast stain, modified acid-fast stain, lactophenol cotton blue (fungal staining)
• Confirmatory biochemical test such as (coagulase, oxidase, catalase, indole)
• Media holds time study.
• Lactobacillus Assay.
• Antibiotic Assay.

Executive Microbiologist - Vellinton Healthcare - Himachal Pradesh

(2020-12 - 2021-10)

• Media preparation and Consumption
• Autoclaving of Culture Media
• Calibration of Ph Meter
• Disposal of Culture Media
• Sterility testing of Raw material & Finished products.
• Culture, subculture, Culture Storage.
• Culture maintenance and Culture preservation and preparation of master culture monthly culture and weekly culture from mother culture, Preparation of culture suspension.

Officer Microbiologist - Gnosis Pharmaceuticals Pvt. Ltd. - Himachal Pradesh

(2018-09 - 2020-11)

• Media Preparation.
• Autoclaving of Media.
• Disposal of Culture Media.
• Microbial limit testing of Raw material and Finished products.
• Microbial limit testing of Purified water.
• Area Monitoring, Temp & Rh monitoring.
• Temp mapping of Lab instruments.
• Fogging.
• Disinfectant Preparation.

Masters of science - Microbiology - C.S.J.M. University (2019)

Bachelor of science - Biotechnology - C.S.J.M. University (2017)

Intermediate - U.P Board (2013)

High School - U.P Board (2011)