Assistant Manager - MJ Biopharma - Pune
(2026-06)
Experienced Microbiology professional with over 12 years of expertise in pharmaceutical Quality Control Microbiology. Currently working as an Assistant Manager, independently leading the Microbiology Department and overseeing day-today laboratory operations, team management, and quality assurance activities. Strong expertise in Quality Risk Management (QRM), Quality Management System (QMS), Change Control, Deviation Management, Incident Investigation, CAPA implementation, Root Cause Analysis, and continuous process improvement.
Well-versed in environmental monitoring, water system monitoring, sterility testing, bacterial endotoxin testing, growth promotion testing, microbial limit testing, and laboratory investigations. Adept at handling regulatory inspections, internal audits, SOP preparation and review, method validation, method transfer, data review, and laboratory compliance
Sr. Executive - Concord Biotech Ltd. - Ahmedabad
(2024-08 - 2026-06)
- Team lead and Microbiology QMS in charge.
- Responsible for Laboratory work planning.
- Training and Development of the subordinates.
- Change Control, Deviation, Incident, OOS investigation.
- Method Validation Protocol preparation for BET, Sterility, MLT & Bio-burden.
- Instrument Qualification, Re-qualification.
- CSV execution.
Executive Microbiology - Aarti Pharmalabs Ltd. - Boisar Maharashtra
(2022-04 - 2024-08)
- Co-ordinate to manage project work.
- Co-ordinate with Manager in handling internal, regulatory audits and audit compliance.
- Supports and provides technical information pertaining to microbiological test to lab management on routine basis.
- Manage laboratory testing, workflow and staff.
- Participate in strategic planning and process improvements.
- Assures timely performance of all activities, including issuance of test status reports.
- Review and check the daily routine analysis and related documentation.
- Preparation of Standard Operating Procedures and validation protocols.
- Handling of Deviation, Incident, Change control, OOS, OOT and Risk assessment.
- Equipment qualifications & validation like Sterility Testing Isolator, HPHV Autoclave.
- Sterility testing of sterile finished product by membrane filtration method (Closed system)
- Analytical method validations of Sterility, Bacterial endotoxin test and Microbial limit test
Jr. Executive Microbiology - Wockhardt Limited - Aurangabad
(2020-01 - 2022-04)
- Team leader for Environmental Monitoring team of 10 person.
- Environmental monitoring planning of sterile injection facility and non sterile facility.
- Coordination with production & QA for EM and work allocation of subordinates.
- Media fill planning, execution, incubation and post observation from the subordinates.
- Investigation of EM excursion, deviations, incidents and taking appropriate CAPA.
- Performed risk assessment, GAP analysis.
- Proactively performed Procurement of media and utilities.
- Review and check the daily routine analysis and related documentation.
- Preparation and execution of new area/ facility EM qualification protocol within timeline.
- Hold Time Study of Microbiological Media, Microbial Culture Suspensions, Swab samples.
- Protocol preparation and execution of EM plates prolong exposure and incubation study.
- SOPs, Specification, STP updating as per requirement.
- Bacterial endotoxin testing of sterile finished pharmaceutical product.
- Disinfectant Efficacy Test
Sr. Officer Microbiology - Indico remedies ltd
(2019-05 - 2020-01)
- Reviewer of Routine analysis section.
- Review and check the daily routine analysis of MLT, Sterility, BET, PET, Water and related documentation.
- Bacterial endotoxin testing of sterile finished pharmaceutical product.
- Analytical method validations of Sterility, Bacterial endotoxin test and Microbial limit test.
- Participated and performed in Aseptic process simulations
- Container Closure Integrity (CCI) study of filled containers.
- Disinfectant Efficacy Test.
Sr. Officer Microbiology - Cipla Ltd. - Verna, Goa
(2018-12 - 2019-05)
- Media preparation.
- Media procurement.
- Media GPT and plate pouring.
- Media management for entire laboratory as per requirement.
- Performed Autoclave validation.
- Media issuance to all the analysis.
Officer Microbiology - Intas Pharmaceutical, SEZ Ahmedabad - Ahmedabad
(2017-03 - 2018-12)
- Environmental Monitoring of clean rooms by Active and Passive method.
- Participated and performed successful Aseptic process simulations
- Sampling and Analysis of Raw water, Purified water, Water for injection and pure steam condensate.
- Sterility testing of finished product.
- Bacterial Endotoxin Test of Finished product, Water for Injections and bulk samples.
- Population enumeration of Biological Indicator
- Container Closure Integrity (CCI) study of filled containers
- Growth Promotion Test (GPT) of culture media
- Preservation and maintenance of Pure Microbial Culture.
Officer Microbiology - Sun Pharmaceutical - Ahmednagar
(2015-11 - 2017-02)
- Growth promotion testing of culture media
- Media preparation and sterilization
- Microbial limit testing of finished products
- Analysis of Raw water, Purified water, Water for injection and Pure steam condensate
- Destruction verification by using biological indicator
- Environmental Monitoring of clean rooms by Active and Passive method.
- Water sampling, Finished sampling, Swab sampling.
- Qualification of Area and Water system.
Trainee Microbiology - Soverign Pharmaceutical - Daman
(2013-08 - 2014-08)
- Growth promotion testing of culture media
- Media preparation and sterilization
- Microbial limit testing of finished products
- Analysis of Raw water, Purified water, Water for injection and Pure steam condensate
- Destruction verification by using biological indicator
- Environmental Monitoring of clean rooms by Active and Passive method.
- Water sampling, Finished sampling, Swab sampling.
