Veeva QMS
Nitheesh Karthikeyan
QA Auditor - GLP/GCP
Alappuzha, Kerala
Summary
Experienced quality assurance auditor with over three years of experience in regulatory compliance and GxP auditing in addition to two years of experience as a quality control analyst and 2.5 years of experience in academic research. Expertise in planning and conducting thorough study specific audits, risk based process audits and facility audits, and hosting sponsor audits. Experienced in risk assessment, root cause analysis, handling of QMS elements, preparation of audit programs, and quality risk management document.
Overview
9
9
years of professional experience
4
4
Languages
Work History
QA Auditor IV, Regulatory Compliance and QA
Labcorp Early Development India Pvt. Ltd
08.2022 - 10.2025
- Conducted thorough study specific audits on protocols, data and reports, and conducted risk based process audits and facility audits following regulations, policies, and SOPs.
- Planned and executed risk based process audit and facility audits programs and assigned the audits to QA auditors in Veeva QMS.
- Liaison with operational team and management regarding the outcome of various audits in a timely manner to facilitate issue resolution.
- Prepared and/or reviewed policies, SOPs, audit programs, risk assessments and quality risk management document (QRM), as required.
- Organized and co-hosted sponsor audits, communicated with external auditors, and responded to the audit findings as required.
Quality Control Executive, Molecular Biology
Biocon Biologics India Ltd
07.2020 - 06.2022
- Conducted testing of in-process and finished products by various methods; purity and identification by SDS-PAGE, detection by polymerase chain reaction (PCR), host cell DNA estimation by quantitative PCR, and identification by western blotting following good laboratory practices and good documentation practices.
- Involved in method validation and method transfer, training of new associates, and daily monitoring of laboratory cleaning and temperature.
- Handled QMS elements such as incidents, OOS, and deviations.
Project Assistant
Rajiv Gandhi Centre for Biotechnology
11.2016 - 04.2019
- Planned and conducted exploratory research on different models of Breast cancer using various cell and molecular biology techniques.
- Authored and reviewed multiple research papers published in international journals.
- Prepared documents for research grant applications and posters for presentation at national and international conferences.
Education
Integrated BS-MS - Life Sciences
Indian Institute of Science Education And Research
Pune05-2016
Skills
GxP Regulations, Regulatory Compliance, FDA GLP, OECD GLP, Toxicology Studies, Risk Assessment, Risk-based Audit Programs, Deviations, Quality Risk Management, Protocol/Data/Report Review
Software
GraphPad- Prism
MS office
Image J
Publications
- Archana P. Thankamony, Sonny Ramkomuth, Shikha T Ramesh, Reshma Murali, Priyanka Chakraborty, Nitheesh Karthikeyan, Binitha Anu Varghese, Vishnu Sunil Jailumar, Mohit Kumar Jolly, Alexander Swarbrick and Radhika Nair (2023). Phenotypic heterogeneity drives differential disease outcome in a mouse model of Triple Negative Breast Cancer. Frontiers in Oncology 13, https://doi.org/10.3389/fonc.2023.1230647
- Archana P. Thankamony*, Reshma Murali*, Nitheesh Karthikeyan, Binitha Anu Varghese, Wee S. Teo, Andrea McFarland, Daniel L. Roden, Holly Holliday, Christina Valbirk Konrad, Aurelie Cazet, Eoin Dodson, Jessica Yang, Laura A. Baker, Jason T. George, Herbert Levine, Mohit Kumar Jolly, Alexander Swarbrick, and Radhika Nair (2020). Targeting the Id1- Kif11 axis in Triple Negative Breast Cancer Using Combination Therapy. Biomolecules 10, 1295 (* Equal contribution) doi: http://doi.org/10.3390/biom10091295
- Wee S. Teo, Holly Holliday*, Nitheesh Karthikeyan*, Aurélie S. Cazet, Daniel L. Roden, Kate Harvey, Christina Valbirk Konrad, Reshma Murali, Binitha Anu Varghese, Archana P. Thankamony, Chia-Ling Chan, Andrea McFarland, Simon Junankar, Sunny Ye, Jessica Yang, Iva Nikolic, Jaynish S. Shah, Laura A. Baker, Ewan K.A. Millar, Mathew J. Naylor, Christopher J. Ormandy, Sunil R. Lakhani, Warren Kaplan, Albert S. Mellick, Sandra A. O’Toole, Radhika Nair#, Alexander Swarbrick#(2020). Id proteins promote a cancer stem cell phenotype in mouse models of triple negative breast cancer via negative regulation of Robo1. Frontiers in Cell and Developmental Biology 8:552, (* Equal contribution). doi: http://doi.org/10.3389/fcell.2020.00552.
- Libi Anandi V, Ashiq KA*, Nitheesh K.*, and Mayurika Lahiri (2016). Platelet activating factor promotes motility in breast cancer cells and disrupts non-transformed breast acinar structures. Oncology reports 35: 179-188. (* Equal contribution) doi: https://doi.org/10.3892/or.2015.4387
Timeline
QA Auditor IV, Regulatory Compliance and QA
Labcorp Early Development India Pvt. Ltd
08.2022 - 10.2025
Quality Control Executive, Molecular Biology
Biocon Biologics India Ltd
07.2020 - 06.2022
Project Assistant
Rajiv Gandhi Centre for Biotechnology
11.2016 - 04.2019
Integrated BS-MS - Life Sciences
Indian Institute of Science Education And Research