GMP QC Microbiologist with 7+ Years
Resume:
Chennai, ******
*****************@*****.***
SUMMARY
Detail-oriented QC Microbiologist
with over 7 years in GMP-regulated
pharmaceutical settings.
Specialises in microbial limit and
growth promotion testing, alongside
microbiological method validation.
Leads contamination investigations
and root cause analyses, ensuring
compliance with industry
standards. Trains teams and
implements process improvements
to elevate product quality.
SKILLS
• Microbial Limit Test (MLT)
• Growth Promotion Testing(GPT)
• Sterility Testing
• Water analysis
• Media preparation
• Microbial identification
• Method validation
Microbiological documentation
review
•
• GMP,GLP,GDP compliance
• SOP Preparation and review
• Regulatory compliance
• LIMS proficiency
• Data Analysis
• Statistical analysis
• Microsoft Excel,Word,Powerpoint
• Deviation investigation
• Culture preservation
Saranya Gottipati
EXPERIENCE
December 2024 - Current
Quality Control Microbiologist ExecutiveAppsCore Solutions Chennai
July 2021 - March 2022
Intern-SAS Programmer Signetsoft Analytics Bangalore Conducted contamination investigations and root cause analysis for microbiological deviations, OOS, OOT, CAPA, and environmental monitoring excursions.
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Analysed microbiological culture media performance to support quality assurance processes.
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• Supported the performance of growth promotion tests in bioballs. Prepared water trends and assisted in performing microbial limit test method for validation.
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Contributed to the microbial limit test method for development validation and verification.
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Reviewed media preparation and stock records to ensure accuracy and compliance.
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Reviewed online documents, analytical reports, and logbooks in the microbiology laboratory.
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Maintained online documentation compliant with GLP, GDP, and GMP standards.
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Enhanced laboratory efficiency through experience with QLMS systems and trained others on laboratory techniques.
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Trained junior staff on laboratory testing procedures through demonstration of key techniques.
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Worked with various microbial hosts for culture maintenance,GPT and microbiological testing.
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Demonstrated proficiency in BASE SAS, SAS SQL, and SAS Macros for data analysis.
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Gained expertise in data analysis and reporting through statistical procedures like PROC FREQ, PROC MEANS, and PROC REPORT.
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Developed SAS programs following Statistical Analysis Plan (SAP) to generate statistical reports, listings, and tables for clinical data analysis.
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Contributed programming efforts for clinical trial drug project, providing support for data reporting and regulatory submissions.
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• Created ADaM data sets as per specifications.
• Created SDTM data sets from raw datasets.
Acquired skills in data extraction and manipulation using diverse functions and statements.
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Assisted programming and statistics lead with project management across various protocol levels, facilitating smoother execution of projects.
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Extensive knowledge of clinical trials (I, II, III, IV phases) in various therapeutic areas such as Neuroscience, General Medicine and Vaccines.
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June 2020 - June 2021
Executive Medreich Pharma Pvt Ltd Bangalore
March 2018 - August 2019
Scientist Vimta Labs Pvt Ltd Hyderabad
September 2016 - February 2018
Junior Executive UNIQUE BIOTECH Pvt Ltd Hyderabad, India Reviewed microbiological culture media and analysed effectiveness to support quality assurance initiatives.
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Conducted growth promotion tests using bioballs to assess microbial viability.
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Reviewed media preparation, stock, consumption records, and growth promotion test documentation to ensure compliance with protocols.
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Performing the Microbial Limit Test Method for development, validation, and verification.
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Preparation of protocols and standard operating procedures for the development, validation, and verification of the product according to the guidelines (USP, BP, EP, and IP).
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Evaluated microbiological culture media for testing effectiveness and analysed performance outcomes.
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Examined media preparation processes, ensuring compliance with quality standards, managing media stock, and reviewing media consumption records and growth promotion test documentation.
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• Analysed requirements to generate actionable insights. Conducted product sampling, ensuring compliance with quality standards.
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Performed microbial limit tests (MLT) on raw materials, finished products, oral suspension, water, and lot powders to maintain product integrity.
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Analysis of Oral Suspension, Regular stability samples, Finished powder samples. Leak test for capsules and suspensions.
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Executed media preparation in line with laboratory protocols, enhancing reliability of experimental outcomes.
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Verified functionality and accuracy of laboratory equipment, ensuring compliance with operational standards and maintaining quality in testing through routine maintenance on control samples. Maintained positive cultures in laboratory settings to support ongoing research and testing.
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Wrote Batch Manufacture Records (BMR) and organised documentation for easy access, ensuring regulatory compliance and efficient information retrieval.
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EDUCATION
2015
MSc. INDUSTRIAL BIOTECHNOLOGY
Bharathiar University, Coimbatore
GPA: 75%
2013
BSc. BIOTECHNOLOGY
DR.NGP Arts and Science College, Coimbatore
GPA: 76%
2010
12th STANDARD (PUC)
St Ann' s Girls Higher Secondary School, Aruvankadu GPA: 57%
CERTIFICATIONS
SAS Global Certification Program for Base Programming Using SAS 9.4
LANGUAGES
English: Telugu:
Tamil: Kannada:
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