Amol Desai
Pune
Summary
Quality-focused professional with 13 years of experience in Pharmaceutical, Bio pharmaceutical, and Cosmetic industries. Expertise in Quality Control and assurance , Research Microbiology, and Regulatory Compliance with strong skills in GMP, GLP, method Validation, and Microbiological Analysis. Proven ability to streamline testing processes, implement SOPs, and ensure compliance, driving continuous process improvements. Encouraging manager, leading and motivating, as well as excellent customer relationship-building skills. Proficient in using independent decision-making skills and multitasking ability. Proven ability to conduct detailed microbial studies and improve testing methodologies. Known for collaborative teamwork.
Overview
14
14
years of professional experience
Work History
Senior Executive Quality and Research
Loreal Research and Innovation
07.2022 - Current
- Established and standardized SOPs for microbiological testing and other process.
- Collaborate with cross-functional teams to develop new products, troubleshoot technical issues, and ensure compliance with relevant regulations and quality standards
- Led the preservative efficacy testing or Challenge testing procedure and antimicrobial studies for new cosmetic formulations skin care, hair care, and similar products
- Review and validate Scientific data and test results.
- Understanding the mechanisms of action of antimicrobial agents, determining shelf life, and analyzing the behavior of preservatives
- Microbial limit test on cosmetics formulations, finish products, RMs and test for specific organisms/pathogens
- Evaluating Surface antifungal properties of cosmetics formulations by surface mold test studies.
- Ensuring Safety in lab by implementing safety validations , risk assessments , work permit for task.
- Identification of Microbial Contaminations and its Investigation with Route cause analysis related corrective and preventive action (CAPA) and compliance
- Managed internal and external audits , ensuring compliance with ISO ,GLP and GMP standards
- Oversight and responsibility for laboratory upkeep, calibration and validation processes, cleanroom qualifications, and the installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of new equipment and instruments
- Microbial ATCC culture revival , stock maintenance and preservation.
- Delivery of presentations, provided microbiological training to concern teams.
- Data interpretation techniques to assist in overcoming technical difficulties and promote continuous improvement
- Using LIMS for systematic data capture and reporting.
Senior Executive Microbiologist QC
Reliance Life Sciences- Sterile Injectable's Processing Plasma proteins and Biosimilars
09.2015 - 07.2022
- To ensure the implementation and maintenance of current, GLP standards accordance with ISO 17025 and testing adhering to USP, IP,BP,FDA and cGMP guidelines .
- Led sterility testing and analytical method validation for plasma protein and bio similar drugs.
- Bacterial Endotoxin test and its analytical method validation for Finish product, drug substance, in-process samples, stability samples
- Bioburden testing, Microbial limit test of in-process samples, drug substance and its method validation
- Microbiological Analysis of Process Water like Purified and WFI.
- Environmental monitoring through Active Air, Passive Air sampling, personal monitoring and surface monitoring, Swab testing of aseptic manufacturing classified area
- Periodic Gowning qualification of personal working in aseptic manufacturing area
- Participate and monitor aseptic media simulation process with visual inspection.
- Cleaning, disinfection validation with disinfectant efficacy testing.
- Endotoxin challenge test for validation of Depyrogenation tunnel/dry heat sterilization and Vial Washers
- Moist heat sterilization/Autoclave validation, biological indicators testing
- Actively participated in the internal and external audits and adherence in compliance to the observations given by auditors
- Prepare and review monthly, and yearly trends on environment monitoring
- Faced audits by CDSCO, WHO, FDA, INVIMA and other customer audits from various countries, sound with 21 CFR part 11 norms.
- Responsible for handling of Quality Management System such as Deviations, change controls, OOS, incidents and handling of CAPA
- Software -: Labware LIMS ver.6 and 8, DMS, trackwise, review of data through LIMS
- Instrumentation and Molecular Biology testing: Protein estimation by Biuret and Kjeldahl method, Sodium content by Atomic absorption Spectroscopy etc., ELISA, Immunological testing
Quality assurance Microbiologist
Galaxy Surfactants Ltd.
01.2013 - 09.2015
- Microbial Limit test, Pathogen testing, Bioburden.
- Challenge test, Minimum Inhibitory Concentration (MIC)and Minimum Bactericidal Concentration (MBC) for antimicrobial agent
- Quality assurance by ensuring Hygiene, Cleaning and sanitization throughout the plant by performing QA checks ,regular hygiene audits, pest control coordination.
- Training to Operators on Microbiological and hygiene aspects.
- HACCP studies and monitoring Critical Control points
Quality Control Analyst
ARISTO PHARMACEUTICALS- Antibiotic Injectable's Manufacturer
06.2011 - 01.2013
- Media preparation and Growth Promotion testing
- Performing BET, Sterility, Microbial limit test, water testing, Environment Monitoring in clean room etc
- Calibration of PH meter, Balance, temperature monitoring of Incubators etc
Education
Master of Science - Microbiology
Pune University
Nashik, India06-2010
Bachelor of Science - Microbiology
Pune University
Nashik, India06-2008
Skills
- Pharmaceutical and Cosmetic Microbiology
- Research and Innovation - Microbiology
- Good Laboratory Practice
- People Management and training
- Audit Management and regulatory compliance
- Analytical Microbiology Validation
- Document Management and SOP preparation
- Quality Management system
- Preservative Efficacy testing
- Cross-functional team coordination
- Microbial Species Identification and Investigations
- Quality control and Quality assurance
- LIMS and LIMS troubleshooting
- Multitasking and quick adaptation skills
Accomplishments
- Won Microbiologist Quiz Competition during college time.
- Special contribution award during COVID pandemic in Reliance Life sciences.
Languages
English
Hindi
Marathi
Projects
Biosurfactant producer organism-Achieved successful characterization of biosurfactants,
contributing to the understanding of their properties and potential
applications- College Project
Cleaning And Sanitization Improvement -A new semi-automatic sprinkler system has been introduced to
improve the cleaning and sanitization procedures for carboys .The implementation and validation of an ozone gas unit within
the current water treatment facility to enhance microbial quality
Automation in Micro. Lab - Loreal Streamlined the deployment process for Automatic Gram
Staining Machine, Automatic Colony counter, and Automatic Spread plate machine.
Timeline
Senior Executive Quality and Research
Loreal Research and Innovation
07.2022 - Current
Senior Executive Microbiologist QC
Reliance Life Sciences- Sterile Injectable's Processing Plasma proteins and Biosimilars
09.2015 - 07.2022
Quality assurance Microbiologist
Galaxy Surfactants Ltd.
01.2013 - 09.2015
Quality Control Analyst
ARISTO PHARMACEUTICALS- Antibiotic Injectable's Manufacturer
06.2011 - 01.2013
Master of Science - Microbiology
Pune University
Bachelor of Science - Microbiology
Pune University
Similar Profiles
Joshua DyerJoshua Dyer
Lab Analyst at Environmental Research and Innovation CenterLab Analyst at Environmental Research and Innovation Center
Gabriella HesterGabriella Hester
DFRACS Research Assistant Intern at University of Minnesota Institute for Social Research and Data InnovationDFRACS Research Assistant Intern at University of Minnesota Institute for Social Research and Data Innovation
Bekir Reha ULAKBekir Reha ULAK
Mechanical Design Engineer at Brussels Research and Innovation Center (BRING)Mechanical Design Engineer at Brussels Research and Innovation Center (BRING)