NIHARIKA GODI
Summary
Quality Assurance and Microbiology professional with 3 + years of experience supporting GMP-compliant quality systems, laboratory operations, and microbiological testing within regulated healthcare and manufacturing environments. Currently working at McBride UK, supporting Quality Management Systems (QMS) through CAPA management, deviation and non-conformance investigations, document control, environmental monitoring, data integrity, audit support, and quality compliance activities. Skilled in root cause analysis (RCA), quality investigations, inspection readiness, trend analysis, and continuous improvement initiatives. Experienced in collaborating with cross-functional teams to maintain compliance, support operational excellence, and ensure high quality standards within regulated environments. Holds a Master's degree in Medical Microbiology from the University of Manchester and is keen to apply quality assurance and microbiology expertise within pharmaceutical, healthcare, and advanced manufacturing organizations.
Overview
4
4
years of professional experience
Work History
Quality Assurance and Control
McBride plc
06.2025 - Current
- Supported Quality Management System (QMS) activities within a GMP-regulated manufacturing environment, ensuring compliance with internal procedures and quality standards.
- Provided quality oversight across manufacturing operations through routine shopfloor presence, and identification of compliance risks.
- Acted as a first point of contact for quality-related issues, supporting operational teams with GMP guidance and quality decision-making.
- Managed deviations, non-conformances, and CAPA processes, including root cause analysis, impact assessment, and effectiveness checks.
- Escalated quality concerns appropriately and supported risk-based decision-making to ensure timely resolution of quality events.
- Maintained inspection readiness through compliance checks, documentation reviews, audit preparation, and closure of quality actions.
- Conducted environmental monitoring activities and trend analysis to identify risks and support continuous improvement.
- Investigated OOS/OOT results, customer complaints, and quality events using structured investigation methodologies.
- Collaborated with Production, Technical, and Quality teams to maintain product quality and support manufacturing operations.
- Supported internal and external GMP audits through documentation preparation, evidence gathering, and implementation of corrective actions.
Volunteer Assistant Technician
The University of Manchester
09.2024 - 12.2024
- Assisted and trained postgraduate students with microbiological testing procedures, analysis, interpretation, and usage of specified equipment.
- Maintained strict compliance with quality control procedures, GLP, laboratory safety protocols, adherence to protocols, COSHH regulations, GMP requirements and cleanliness.
- Supported in inventory management, equipment maintenance and troubleshooting, leading to a 20% improvement in lab efficiency.
Laboratory Technician
Seven Hills Hospital
01.2023 - 08.2023
- Conducted microbiological and biochemical analysis of clinical samples daily (e.g., blood, urine, sputum) using staining, culturing, microscopy, and biochemical assays.
- Performed serological testing and ELISA for diagnostic applications, followed by evaluating the COVID samples.
- Carried out antimicrobial susceptibility testing using Kirby-Bauer disk diffusion methods.
- Operated and maintained analytical instruments, including centrifuges, pH meters, and clinical analyzers (Auto/Semi-Auto).
- Ensured accurate sample labeling, documentation, and storage per laboratory protocols and GLP standards.
- Collaborated with consultants by recording, reporting, and communicating critical results effectively.
- Strictly followed SOPs, PPE use, and COSHH regulations to reduce contamination and ensure safety when handling hazardous materials.
- Proposed improvements to routine procedures, contributing to more efficient diagnostics and turnaround times.
Laboratory Technician
Bio Enviro Chemical Solutions Laboratory
02.2022 - 10.2022
- Performed microbiological testing of water and environmental samples using standard methods.
- Interpreted microbiological results, flagged non-conformances, and suggested corrective actions.
- Maintained equipment calibration logs and ensured compliance with GLP.
- Prepared reagents and media; sterilized tools and surfaces for hygienic processing.
- Recorded and evaluated batch results, supporting QA decision-making.
Education
Master's - Medical Microbiology
THE UNIVERSITY OF MANCHESTER
UK01-2024
Master's - General Microbiology
ANDHRA UNIVERSITY
India01-2021
Bachelor's Degree - Biotechnology, Biochemistry & Chemistry
St. JOSEPH'S COLLEGE FOR WOMEN (AFFILIATED TO ANDHRA UNIVERSITY)
India01-2019
Skills
- Good Manufacturing Practice (GMP)
- Good Laboratory Practice (GLP)
- Quality Management Systems (QMS)
- Regulatory compliance
- Audit preparation
- Inspection readiness
- CAPA management
- Deviation handling
- Non-conformance investigations
- Out-of-Specification (OOS) investigations
- Out-of-Trend (OOT) investigations
- Root cause analysis (RCA)
- Data integrity principles
- Continuous improvement activities
- Standard Operating Procedure (SOP) management
- Document lifecycle control
- Record management
- Traceability of quality records
- Microbiological testing
- Environmental monitoring
- Clinical sample analysis
- Environmental sample analysis
- Serological techniques
- Molecular techniques
- ELISA
- PCR
- Antimicrobial susceptibility testing
- Aseptic techniques
- Microbial culture and identification
- Data interpretation
- Compliance with quality standards
- ISO standards
- LIMS
- SAP (ECC/S4HANA)
- Electronic document management systems
- Analytical thinking
- Problem solving
- Attention to detail
- Teamwork
- Communication skills
- Time management
- Ability to work in fast-paced regulated environments
Languages
- English (Highly proficient)
- Hindi
- Telugu
Projects
- Fungal and Viral Co-Infection, The University of Manchester, 06/2024, 09/2024, Manchester, England, Investigated fungal and viral co-infection in primary airway epithelial cells., Measured cytokine release (IL-8) and LDH for cell damage assessment., Used ELISA and RT-PCR to study pathogen interactions and immune response.
- Microbial Analysis of Water, Laurus Laboratories, 02/2021, 02/2021, Hyderabad, Telangana, Conducted microbial analysis of water samples to ensure compliance with quality standards., Performed production-related testing of manufactured medicines, including environmental monitoring in production areas.
Technical Tools And Equipment
MS Office, SAP S/4HANA, SAP ECC, Python, ImageJ, GraphPad Prism, LIMS, Bio-Edit, QIAamp DNA Mini Kit, Genesys 180 UV Spectrophotometer, SimpliAmp Thermal Cycler, Fluorescence microscope, Laminar Air flow systems, Electrophoresis systems, Centrifuge, Millicell-ERS Volt-Ohm meter, nanodrop, Myra automatic liquid handling system, qubit dsDNA assay, Multiskan FC Microplate Photometer, Hot air oven, Forma Direct Heat CO2 Incubator
Core Competencies
Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), ISO standards, Quality Management Systems (QMS), regulatory compliance, audit preparation and inspection readiness, data integrity principles, CAPA management, deviation handling, non-conformance investigations, Out-of-Specification (OOS) and Out-of-Trend (OOT) investigations, root cause analysis (RCA), continuous improvement activities, Standard Operating Procedure (SOP) management, document lifecycle control, record management, traceability of quality records, Microbiological testing, environmental monitoring, clinical and environmental sample analysis, serological and molecular techniques (ELISA, PCR), antimicrobial susceptibility testing, aseptic techniques, microbial culture and identification, data interpretation, compliance with quality standards, LIMS, SAP (ECC/S4HANA), electronic document management systems, Attention to detail, problem solving, analytical thinking, communication skills, teamwork, time management, ability to work in fast-paced regulated environments
Timeline
Quality Assurance and Control
McBride plc
06.2025 - Current
Volunteer Assistant Technician
The University of Manchester
09.2024 - 12.2024
Laboratory Technician
Seven Hills Hospital
01.2023 - 08.2023
Laboratory Technician
Bio Enviro Chemical Solutions Laboratory
02.2022 - 10.2022
Master's - Medical Microbiology
THE UNIVERSITY OF MANCHESTER
Master's - General Microbiology
ANDHRA UNIVERSITY
Bachelor's Degree - Biotechnology, Biochemistry & Chemistry
St. JOSEPH'S COLLEGE FOR WOMEN (AFFILIATED TO ANDHRA UNIVERSITY)